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CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

4. november 2026 oppdatert av: Liping Dou

A Single-Arm, Dose-Escalation Clinical Study on the Safety of CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to evaluate the safety, tolerability, preliminary efficacy, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The investigational product is a targeted lentiviral vector that transduces the patient's endogenous T/NK cells in situ; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Participants receive an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the Day 7 infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, which reflects the success of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade and current control of adverse events occurring after the first infusion, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS); and (iii) the participant's general condition, including Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation). The second infusion will be postponed or cancelled if any of these assessments indicates that the risk outweighs the benefit, for example grade >=3 CRS or grade >=2 ICANS that has not resolved to grade <=1, or investigator-judged deterioration in organ function. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10^9, 3×10^9, and 6×10^9 transducing units (TU), guided by dose-limiting toxicities (DLTs) assessed during Days 0-28; higher dose levels may be explored if the maximum tolerated dose is not reached. Treatment-emergent adverse events and serious adverse events, including CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and organ toxicity, will be assessed. Preliminary antitumor activity will be evaluated by objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and the expansion and persistence of in vivo-generated CAR-T cells in peripheral blood will also be evaluated.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Rekruttering

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Detaljert beskrivelse

This is a single-center, single-arm, open-label, prospective, investigator-initiated clinical study of CD19 sequential CD22 in vivo CAR-T cell immunotherapy in adults with R/R B-ALL whose tumor cells express CD19 and CD22. The investigational product is an engineered lentiviral vector in which the receptor-binding domain of the viral envelope has been mutated to abolish its native pantropic infectivity, and a targeting module composed of an anti-CD7 nanobody (VHH) and a T/NK-cell-specific ligand (CD58 extracellular domain) has been incorporated into the envelope, enabling specific transduction of circulating T cells and NK cells in situ and expression of a CAR directed against CD19 (first infusion) or CD22 (second infusion); no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Treatment consists of an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0 and an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the second infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, used to evaluate the efficiency of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade, current grade, and response to management of CRS, ICANS, and other adverse events occurring after the first infusion; and (iii) general condition, including ECOG performance status, vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation), and infection status. Participants who meet the criteria for continued dosing will receive the second infusion as planned. The second infusion will be postponed if grade >=3 CRS or grade >=2 ICANS occurs and does not resolve to grade <=1, or if the investigator judges that continued dosing carries a risk exceeding the potential benefit; if the participant does not recover to a state permitting dosing within the prespecified window, the second infusion will be cancelled and the participant will continue protocol-specified safety follow-up and efficacy assessment. Three dose levels are planned (1×10^9, 3×10^9, and 6×10^9 TU) using a traditional 3+3 escalation design, and the DLT observation window is Days 0-28 after treatment; upon completion of DLT observation at the highest planned dose level without reaching the maximum tolerated dose (MTD), the investigator may explore higher dose levels based on accumulated safety and pharmacodynamic data. Planned enrollment is 12 participants. The study includes a screening period (within 28 days), a treatment period, and a follow-up period of up to 24 months. Safety assessments include adverse events and serious adverse events graded per NCI CTCAE v5.0, with CRS and ICANS graded per the ASTCT consensus criteria; hematologic toxicity, infection, organ toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), tumor lysis syndrome (TLS), and viral shedding (peripheral blood, saliva, and urine) are also monitored. Disease response is assessed by bone marrow morphology and multiparameter flow cytometry (CR and CRi), with measurable residual disease (MRD) assessed in bone marrow and cerebrospinal fluid. Exploratory cellular kinetics include peripheral blood CAR transgene copies (qPCR) and CAR-positive cell counts, with sampling planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion, and derivation of peak expansion (Cmax), time to peak (Tmax), and the area under the curve from Day 0 to Day 28 (AUC0-28d). Because the investigational product is an integrating lentiviral vector, participants will be enrolled in a long-term safety follow-up program for the detection of delayed adverse events, in accordance with the applicable guidance on gene therapy products; the duration, schedule, and responsible parties are specified in the protocol.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
12

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Rekruttering
        • Chinese PLA General Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

14 år til 75 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
  • Diagnosis of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) according to the World Health Organization (WHO) classification, confirmed by bone marrow aspirate morphology, flow cytometry, or histopathology, with tumor cells shown by immunophenotyping or flow cytometry to express CD19 and CD22. Relapsed/refractory B-ALL is defined as meeting at least one of the following four criteria:

Relapse within 6 months after first remission; Primary refractory disease: failure to achieve complete remission after 2 cycles of standard chemotherapy; Failure to achieve complete remission or relapse after one or more lines of salvage chemotherapy; Relapse after hematopoietic stem cell transplantation.

  • Male or female participants aged 14 to 75 years, inclusive.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Estimated life expectancy of more than 3 months from the date of signing the informed consent form.
  • Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows:

Creatinine clearance (estimated by the Cockcroft-Gault formula) ≥60 mL/min or serum creatinine ≤1.5 × the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), total bilirubin≤1.5×ULN; Cardiac ejection fraction≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on electrocardiogram (ECG); No clinically significant pleural effusion, and oxygen saturation >92% on room air at baseline.

  • Participants of reproductive potential must agree to use highly effective contraception before enrollment and for at least 12 months after SL1CC infusion. A negative serum pregnancy test is required for women of childbearing potential at screening. Participants must immediately notify the investigator if pregnancy occurs or is suspected.

Exclusion Criteria:

  • The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) <50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
  • A history of severe pulmonary disease associated with impaired lung function.
  • Concurrent progressive malignancy other than acute lymphoblastic leukemia.
  • Severe active infection that cannot be effectively controlled, defined as sepsis or an infection with an uncontrolled infectious focus. Participants may be enrolled after the infection has been adequately controlled.
  • Severe autoimmune disease or congenital immunodeficiency.
  • Active hepatitis B or hepatitis C infection, defined as hepatitis B virus DNA (HBV DNA) or hepatitis C virus RNA (HCV RNA) levels above the lower limit of detection.
  • Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period.
  • History of severe immediate hypersensitivity reactions to any drug required in this study, including antibiotics, or to biological products.
  • Prior treatment with any gene therapy product or any in vivo CAR-T therapy, or known pre-existing neutralizing immunity to the lentiviral vector.
  • Active central nervous system (CNS) leukemia or leptomeningeal involvement not controlled after adequate intrathecal therapy; cerebrospinal fluid examination is required during screening.
  • The patient has severe autoimmune disease, congenital immunodeficiency or active autoimmune disease requiring ongoing systemic immunosuppressive treatment, or is currently within the washout period after having received medications that may affect CAR-T cell immunotherapy, or is anticipated to require medications during the study period that may affect CAR-T cell immunotherapy treatment, or active GVHD requiring systemic therapy.
  • Pregnancy or breastfeeding (lactation).
  • The investigator judges that the patient is unlikely to complete all visits and procedures required by the study protocol (including medium- and long-term follow-up visits), such as insufficient willingness of the patient and their family members to participate in the study, refusal to participate, inability of the patient to fully cooperate with the study arrangements, or inadequate compliance on the part of the patient and their family members.
  • Any other severe physical or psychiatric disorder or clinically significant laboratory abnormality that may increase the risk associated with study participation, interfere with the interpretation of study results, or, in the investigator's judgment, make the participant unsuitable for participation in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: The experimental group

In Vivo CAR-T Treatment Group - sequential intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by CD22-targeted in vivo CAR-T on Day 7, at one of three planned dose levels (1×10^9, 3×10^9, or 6×10^9 TU) assigned by a traditional 3+3 dose-escalation design; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is administered. Before the second infusion, the investigator must assess (i) the proportion of CAR-positive T/NK cells in peripheral blood, (ii) the maximum grade and current control of CRS, ICANS, and other adverse events after the first infusion, and (iii) ECOG performance status and vital organ function, in order to determine whether the second infusion should proceed as planned; the second infusion will be postponed or cancelled in participants with grade >=3 CRS or grade >=2 ICANS that has not resolved to grade <=1. Higher dose levels may be explored if the maximum tolerated dose is not reached.
Legemiddel: CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7)

The investigational products are engineered lentiviral vector-based in vivo gene therapy products. The viral envelope receptor-binding domain has been mutated to abolish native pantropic infectivity, and a targeting module composed of an anti-CD7 nanobody (VHH) and a T/NK-cell-specific ligand (CD58 extracellular domain) has been incorporated into the envelope, enabling specific transduction of circulating T cells and NK cells in situ and expression of a chimeric antigen receptor directed against CD19 (first infusion, Day 0) or CD22 (second infusion, Day 7). No leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10^9, 3×10^9, and 6×10^9 transducing units (TU), guided by the occurrence of dose-limiting toxicities (DLTs).

Andre navn:
  • In vivo CD19/CD22 CAR-T; targeted lentiviral vector for in vivo CAR-T generation

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety and Tolerability
Tidsramme: From the first in vivo CAR-T infusion through 12 months after treatment

DLTs, the number and percentage of participants who experience DLT during the protocol-defined DLT observation period (Days 0-28) after the first in vivo CAR-T infusion.
From the first in vivo CAR-T infusion through 12 months after treatment
Adverse Events
Tidsramme: From the first in vivo CAR-T infusion through 12 months after treatment

AEs are graded per NCI CTCAE v5.0
From the first in vivo CAR-T infusion through 12 months after treatment
Cytokine Release Syndrome
Tidsramme: From the first in vivo CAR-T infusion through 12 months after treatment

Cytokine release syndrome (CRS) is graded according to the ASTCT consensus criteria.
From the first in vivo CAR-T infusion through 12 months after treatment
Immune Effector Cell-associated Neurotoxicity Syndrome
Tidsramme: From the first in vivo CAR-T infusion through 12 months after treatment

immune effector cell-associated neurotoxicity syndrome (ICANS) is graded according to the ASTCT consensus criteria.
From the first in vivo CAR-T infusion through 12 months after treatment

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate at Prespecified Follow-up Time Points
Tidsramme: From the first in vivo CAR-T infusion through 24 months after treatment

The objective response rate (ORR) at 1, 2, 3, 6, 9, 12, 18, and 24 months after treatment, defined as the proportion of participants who achieve a complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with incomplete platelet recovery (CRp). The ORR at 3 months after treatment is the key evaluation time point.
From the first in vivo CAR-T infusion through 24 months after treatment
Overall Survival
Tidsramme: From the first in vivo CAR-T infusion through 24 months after treatment

Overall survival (OS), defined as the time from the first in vivo CAR-T infusion to death from any cause. Participants who are alive at the last follow-up will be censored on the date of their last known survival status.
From the first in vivo CAR-T infusion through 24 months after treatment
Progression-Free Survival
Tidsramme: From the first in vivo CAR-T infusion through 24 months after treatment

Progression-free survival (PFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression or death from any cause, whichever occurs first.
From the first in vivo CAR-T infusion through 24 months after treatment
Event-Free Survival
Tidsramme: From the first in vivo CAR-T infusion through 24 months after treatment

Event-free survival (EFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression, relapse, or death from any cause, whichever occurs first.
From the first in vivo CAR-T infusion through 24 months after treatment
Measurable Residual Disease (MRD) Negativity Rate
Tidsramme: At Day 28 and Months 2, 3, 6, 9, 12, 18, and 24 after the first in vivo CAR-T infusion

The proportion of participants with MRD negativity in bone marrow assessed by multiparameter flow cytometry among participants who achieve CR/CRi, at each prespecified assessment time point.
At Day 28 and Months 2, 3, 6, 9, 12, 18, and 24 after the first in vivo CAR-T infusion
Cellular Kinetics (Pharmacokinetics) of In Vivo-Generated CAR-T Cells (Exploratory)
Tidsramme: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion

CAR transgene copy number in peripheral blood (qPCR), peak expansion of CAR-T cells in peripheral blood (Cmax).
Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion
Time to Peak Expansion
Tidsramme: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion

Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion.
Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion
Area Under The Curve From Day 0 to Day 28
Tidsramme: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion

The area under the curve from Day 0 to Day 28 (AUC0-28d).Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion.
Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
Liping Dou

Samarbeidspartnere

Samarbeidspartnere

En annen organisasjon enn sponsoren som gir støtte til en klinisk studie. Denne støtten kan omfatte aktiviteter knyttet til finansiering, design, implementering, dataanalyse eller rapportering.
Hebei Senlang Biotechnology Inc., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
1. september 2026

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
31. august 2028

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
31. august 2029

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
28. oktober 2026

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
4. november 2026

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
4. november 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • 2026-749

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Innstillinger for informasjonskapsler

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