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CD70.CAR for AML and Other CD70+ Leukemias (CASEY)

10. november 2026 opdateret af: Bilal Omer, Baylor College of Medicine

Chimeric Antigen Receptor Treatment Targeting AML and Other CD70 (SEVENTY) Positive Leukemias

This study is for patients who have a type of blood cancer that expresses the protein CD70, which includes acute myeloid leukemia (AML), T-cell leukemia or B-cell leukemia (and the leukemia has come back or has not gone away after standard of care treatment).

As there are limited or no remaining standard treatments available to treat this cancer, subjects are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the leukemia cells in a subject's body.

The body has different ways of fighting infection and disease. This research study combines different ways of fighting disease by using T cells and "arming" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients.

T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.

The protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to leukemia cells when it binds to CD70. CD70 binders have been used to treat people with leukemia. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor or "CAR T cell". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the "CAR T cells" to kill blood cancer cells which are confirmed to have CD70.

In the laboratory, investigators have found that T cells work better if there are proteins added which stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on leukemia cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the leukemia cells.

These CD70 "CAR" T cells are investigational products not approved by the Food and Drug Administration.

The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with leukemia.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Prior to enrollment in this study the patient will have given blood to make CD70 CAR T cells in the laboratory. These cells are kept frozen until they are given to the patient. To make the T cells the patients' blood will be stimulated with growth factors to make the T cells grow. To get the CD70 binder to attach to the surface of the T cell, the gene is inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps find the T cells the patients' blood after being injected. To ensure the T cells grow well in the lab, investigators may add small amounts of medications that are often used to treat patients with cancer or other illnesses. These medications are washed off of the cells prior to injecting them into the body. Because the patient will receive cells with a new gene in them, they will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. If patient cannot visit the clinic, they may be contacted by the research coordinator or physician by phone or in other ways.

Once patient is enrolled to this study they will be assigned a dose of CD70 CAR T cells. Studies suggest that the infused T cells need room to be able to grow and accomplish their functions, as such the patient will receive lymphodepleting chemotherapy with 3 daily doses of cyclophosphamide and fludarabine, ending at least one day prior to receiving the CD70 CAR T cells. These drugs will decrease the number of the patients own T cells before being infused with the CD70 CAR T cells and also will help decrease the number of other cells that may interfere with the CAR T cells working well.

The patient will be given an injection of cells into the vein through an IV at the assigned dose of CD70 CAR T cells. Before receiving the T cell infusion, patients will be given a dose of Benadryl and Tylenol. Patients may be admitted as an inpatient for at least 72 hours for observation in case any potential side effects occur following infusion. Patients will have to remain locally for at least 4 weeks after the infusion. If patient experiences any side effects they may have to be hospitalized for evaluation and management.

The treatment will be given by the Center for Cell and Gene Therapy at Texas Children 's Hospital or Houston Methodist Hospital.

STANDARD MEDICAL TESTS BEFORE TREATMENT:

  • Physical exam and History
  • Blood tests to measure blood cells, kidney and liver function
  • Measurements of the tumor by scans and/or bone marrow studies
  • Testing of the blood for certain viral infections
  • An ultrasound of the heart to make sure the heart function is appropriate for the study if patient has not had one recently

STANDARD MEDICAL TESTS DURING TREATMENT AND AFTER:

  • Physical exams and History
  • Blood tests to measure blood cells, kidney and liver function
  • Measurements of the tumor by scans and/or bone marrow studies 4 weeks after the infusion.

To learn more about the way the CD70 CAR T cells are working and how long they last in the body, extra blood will be drawn. The total amount on any day is about 10 teaspoons (50 ml) or no more than 3 ml per 2.2 pounds (3 ml per kilogram) body weight in children. This volume is considered safe but may be decreased if the patient is anemic (decreased number of red blood cells). Blood will be taken before starting the chemotherapy a few days prior to the cell infusion. On the day the patient receives the cells, blood will be taken before the cells are given and several hours afterwards. Other blood will be drawn one week after the infusion, 2 weeks, 3 weeks, 4 weeks 6 and 8 weeks after the infusion, at 3 months, at 6 months, at 9 months, at 1 year, every 6 months for 4 years, then yearly for a total of 15 years.

If the patient has a biopsy of their tumor or bone marrow studies in the future after completing this study, the investigators may ask to have a piece of tumor or bone marrow to look for CD70 CAR T cells.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
78

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

Ikke ældre end 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Procurement Inclusion Criteria:

  1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL). Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors or anti-CD33 drug conjugate)

    OR

    Patients with other relapsed or refractory CD70+ leukemia that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. (CD19+ leukemia only: Patients must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.)

    Primary refractory or resistant disease, for purposes of procurement, defined as not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 1 to 2 cycles of intense induction therapy.

    Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts >=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)

  2. CD70 positive leukemia with at least 26% CD70+ blasts by flow cytometry or immunohistochemistry (staining can be pending at time of procurement)

  3. Age ≤75 years. NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)

  4. Hemoglobin ≥ 7.0 g/dL (can be transfused)

  5. If apheresis required to collect blood

    • PT and aPTT <1.5x ULN
    • Serum Creatinine < 2 x ULN
    • AST < 5 x ULN

  6. Informed consent.

Procurement Exclusion Criteria:

  1. Diagnosis of acute promyelocytic leukemia (APL)
  2. Active infection (bacterial, fungal, or viral) requiring ongoing treatment without improvement.
  3. Known active infection with HIV or HTLV (collected blood will be sent for HIV/HTLV testing, separate testing prior to procurement not required). Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is >350 mm^3.
  4. Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment
  5. Ongoing treatment with immune suppression for prophylaxis/treatment of GVHD including high dose steroids (e.g. prednisone equivalent > 0.5 mg/kg/day)

Treatment Inclusion Criteria:

  1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors, or anti-CD33 drug conjugate).

    OR

    Patients with other relapsed or refractory CD70+ hematological leukemias that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. Patients with CD19+ malignancies must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.

    Primary refractory or resistant disease as defined by not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 2 cycles of intense induction therapy. Patients with no reduction in blast count after the first cycle or with p53 mutations without CR after the first cycle of intense induction therapy are also considered primary refractory.

    Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts >=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)

  2. Confirmation from the patient's primary physician team of a suitable allogeneic hematopoietic stem cell transplant (HSCT) donor.

    OR Documentation that patient declines a potential subsequent HSCT)

  3. CD70 positive leukemia with at least 26% CD70+ cells by flow cytometry or immunohistochemistry (tissue)

  4. No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment.

  5. Age ≤ 75 years. NOTE: The first three (3) patients treated on the study should be adults (≥18 years of age). Thereafter, a thorough review of the safety data will be performed and submitted to the FDA for approval prior to enrolling pediatric patients.

  6. Hemoglobin ≥ 7.0 g/dL (can be transfused)

  7. Total bilirubin < 3 times the upper limit of normal

  8. AST/ALT < 5 times the upper limit of normal

  9. Estimated GFR ≥ 60ml/min

  10. Pulse oximetry of > 90% on room air

  11. Karnofsky/Lansky score of ≥ 60%

  12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. Male partner should use a condom

  13. Informed consent obtained.

Treatment Exclusion Criteria:

  1. Diagnosis of acute promyelocytic leukemia (APL)
  2. Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks.
  3. Pregnant or lactating.
  4. Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is >350 mm^3.
  5. Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.
  6. Cardiac abnormalities: Cardiac echocardiography with LVEF<50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions within 6 months of treatment.
  7. Presence of CNS disease: Defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm^3 or known CNS tumors/chloromas (repeat spinal tap within 4 weeks only required for leukemia patients with known CNS disease)
  8. Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days
  9. Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days
  10. Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD
  11. High dose steroids >1 mg/kg within preceding 5 days or currently receiving >0.5mg/kg/day prednisone equivalent
  12. Hyperleukocytosis (WBC ≥ 50K) or rapidly progressive disease that in the estimation of the investigator would compromise the ability of the patient to complete the initial 6 weeks of the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Treatment Arm A

Patients will initially be consented for procurement of blood for generation of the transduced T-cells.

Three dose levels will be evaluated and a possible dose level -1 in case of unexpected toxicity at dose level 1. Each patient will receive one T cell infusion.
Biologisk: Treatment Arm A

Each patient will receive one T cell infusion.

CD70.CAR Dose Levels / Cell Dose (transduced cells):

Dose Level -1: 3 x 10^5 cells/kg Dose Level 1 (starting dose level): 1 x 10^6 cells/kg Dose Level 2: 3 x 10^6 cells/kg Dose Level 3: 1 x 10^7 cells/kg

*First three patients treated on the study will be adults 18 years of age or older.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose limiting toxicity (DLT) rate
Tidsramme: Time Frame 4 weeks post infusion

1. Dose-limiting toxicity (CTCAE v5.0) is defined as any grade 3 or 4 non-hematologic toxicities (including allergic reactions and ICANS) that fails to return to Grade 2 within 72 hours or any grade 5 toxicity (additional assessment criteria may apply).
Time Frame 4 weeks post infusion

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: Time Frame 4 weeks post infusion

1. Response rate by International Working Group Criteria for AML and disease specific response criteria for patients with other hematological malignancies.

The response rate for AML is calculated as the overall complete response rate (CRMRD- + CR + CRi)
Time Frame 4 weeks post infusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Baylor College of Medicine

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
The Methodist Hospital Research Institute

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Bilal Omer, MD, Baylor College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
15. april 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. juni 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. juni 2044

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
28. marts 2024

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
28. marts 2024

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
3. april 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
10. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • H-53163 CASEY

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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