- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05194709
Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors
18. januar 2022 oppdatert av: Wuxi People's Hospital
Clinical Trial of Anti-5T4 Oncofetal Trophoblast Glycoprotein (5T4) Conjugated Antibody Redirecting Natural Killer (CAR-NK) Cells in Advanced Solid Tumors
This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The treatment cycle in this study is 21 days.
The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle.
Subjects will be treated continuously until the criteria for termination of treatment are met.
In this study, the dose escalation design is adopted.
The first administration dose in the first cycle is 3.0×10^9 cells.
If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10^9 cells.
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Peihua Lu, MD
- Telefonnummer: +8613583991399
- E-post: lyzlyylxm@163.com
Studiesteder
-
-
Jiangsu
-
Wuxi, Jiangsu, Kina
- Rekruttering
- Wuxi People's Hospital
-
Ta kontakt med:
- Peihua Lu, MD
- Telefonnummer: +8613583991399
- E-post: lyzlyylxm@163.com
-
-
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
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
- Age: adult at the age of 18-80 (both inclusive), female or male.
- Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who had failed standard therapy, or had no standard therapy, or were not eligible for standard therapy at this stage; tumor biomarkers combined with imaging can be used to diagnose some special advanced tumors.
- Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time >3 months.
Organ function during screening should meet the following criteria:
- Absolute neutrophil count (ANC)≥0.8×109/L
- Platelet (PLT)≥50×109/L
- Hemoglobin (Hb)≥80g/L
- Total bilirubin (TBIL)≤2×ULN
- Alanine aminotransferase (ALT)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
- Aspartate aminotransferase (AST)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
- Creatinine (Cr)≤1.5× ULN
- Creatinine clearance (Ccr) (to be calculated only when Cr > 1.5× ULN)>50ml/min/1.73m2 (Cockcroft-Gault formula)
- Activated partial thrombin time (APTT)≤1.5×ULN
- International normalized ratio (INR)≤1.5×ULN
- Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods (hormonal or barrier methods or abstinence, etc.) for 6 months from signing the ICF until the last dose of the study drug is administered; women of reproductive age should not be pregnant or breastfeeding.
Exclusion Criteria:
- Have received systemic antitumor therapy, including chemotherapy, immunotherapy, and radical radiotherapy, within 1 week prior to their first use of the study drug.
- Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.
- Any prior adoptive cellular immunotherapy.
- Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
- Patients with severe infections that cannot be controlled.
- Patients with a known history of human immunodeficiency virus (HIV) infection, or a history of organ transplantation.
- Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission).
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
- The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male>450ms, female>470ms);
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;
- Patients with heart failure or left ventricular ejection fraction (LVEF) < 50% in the New York Heart Association (NYHA) classification ≥II;
- Hypertension beyond clinical control.
- Adverse effects of previous antineoplastic therapy have not returned to CTCAE grade 5.0≤2 (except for toxicity that the investigator determined to be of no safety risk, such as alopecia, hypothyroidism stabilized by hormone replacement therapy).
- Central nervous system metastases with clinical symptoms.
- Had other malignant tumors in the past 3 years, excluding skin basal cell carcinoma, ductal carcinoma in situ and cervical carcinoma in situ with a radical surgery.
- Have a history of alcohol or drug abuse or mental disorder.
- The investigator considered that the subjects had a history of other serious systemic diseases or other reasons that made them unsuitable for 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 |
Intervensjon / Behandling |
---|---|
Eksperimentell: Anti-5T4 CAR-NK Cells
|
The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days).
The first administration dose in the first cycle is 3.0×10^9 cells.
If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10^9 cells.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Adverse Events (AEs)
Tidsramme: From day 1 to day 90 after the last dose
|
To evaluate the safety and tolerability of anti-5T4 CAR-NK cells
|
From day 1 to day 90 after the last dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Objective response rate (ORR)
Tidsramme: Up to 1 year after infusion
|
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
|
Up to 1 year after infusion
|
Progression-free survival (PFS)
Tidsramme: Up to 1 year after infusion
|
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
|
Up to 1 year after infusion
|
Overall survival (OS)
Tidsramme: Up to 1 year after infusion
|
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
|
Up to 1 year after infusion
|
Disease control rate (DCR)
Tidsramme: Up to 1 year after infusion
|
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
|
Up to 1 year after infusion
|
Cytokine release
Tidsramme: Up to 1 year
|
Blood samples will be collected at specified time points to detect the cytokine (IL-1β, IL-2, IL-4, IL-6, IL-10, IFN-γ, hsCRP) concentration (pg/mL)
|
Up to 1 year
|
Lymphocyte subtype
Tidsramme: Up to 1 year
|
Blood samples will be collected at specified time points to analyze the lymphocyte subtypes (CD3, CD4, CD8, CD19, CD56)
|
Up to 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Peihua P Lu, MD, Wuxi People's Hospital
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)
30. desember 2021
Primær fullføring (Forventet)
30. desember 2022
Studiet fullført (Forventet)
30. desember 2022
Datoer for studieregistrering
Først innsendt
4. januar 2022
Først innsendt som oppfylte QC-kriteriene
14. januar 2022
Først lagt ut (Faktiske)
18. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IBR854-T01
- WX-IBR-8 (Annen identifikator: Wuxi People's Hospital)
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. .
Kliniske studier på Avanserte solide svulster
-
I-Mab Biopharma Co. Ltd.Ikke lenger tilgjengeligSolid Tumor Metastatic Cancer Advanced Cancer
-
Shanghai Pudong HospitalUTC Therapeutics Inc.TilbaketrukketMesothelin-positive Advanced Refractory Solid TumorsKina
-
Novartis PharmaceuticalsFullførtcMET Dysegulation Advanced Solid TumorsØsterrike, Danmark, Sverige, Storbritannia, Spania, Tyskland, Nederland, Forente stater
-
Agenus Inc.FullførtAvansert solid kreft | Advanced Solid Cancers Refractory to PD-1Forente stater
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRekrutteringKRAS G12C Mutant Advanced Solid TumorsKina
-
AmgenAktiv, ikke rekrutterendeKRAS p.G12C Mutant Advanced Solid TumorsForente stater, Frankrike, Canada, Spania, Belgia, Korea, Republikken, Østerrike, Australia, Ungarn, Hellas, Tyskland, Japan, Romania, Sveits, Brasil, Portugal
-
Istituto Clinico HumanitasFullført
-
Incyte CorporationAvsluttetSolid tumor malignitetForente stater, Frankrike, Storbritannia, Italia, Korea, Republikken, Japan, Spania, Israel, Danmark, Tyskland, Sveits
-
Martin GutierrezHackensack Meridian Health; Karyopharm Therapeutics IncTilbaketrukket
-
Cytovation ASMerck Sharp & Dohme LLCAktiv, ikke rekrutterendeAvansert solid tumor malignitetNederland, Frankrike, Spania
Kliniske studier på Anti-CAR-NK Cells
-
Chongqing Public Health Medical CenterZhejiang Qixin Biotech; Chongqing Sidemu BiotechUkjent
-
Hangzhou Cheetah Cell Therapeutics Co., LtdAvsluttetSikkerhet og effektivitetKina
-
Henan Cancer HospitalHar ikke rekruttert ennåIkke-småcellet lungekreft NSCLC
-
Allife Medical Science and Technology Co., Ltd.UkjentRefraktært B-celle lymfom
-
Allife Medical Science and Technology Co., Ltd.UkjentRefraktært B-celle lymfom
-
Shanghai General Hospital, Shanghai Jiao Tong University...RekrutteringTilbakefallende AML for voksne | Ildfast AMLKina
-
Allife Medical Science and Technology Co., Ltd.Peking University Cancer Hospital & InstituteUkjentRefraktært B-celle lymfom
-
Asclepius Technology Company Group (Suzhou) Co....UkjentBukspyttkjertelkreftKina
-
Second Affiliated Hospital, School of Medicine,...RekrutteringB-celle non-hodgkin lymfomKina
-
Second Affiliated Hospital, School of Medicine,...Har ikke rekruttert ennåMantelcellelymfom (MCL) | Primært mediastinalt B-celle lymfom (PMBCL) | Diffust storcellet B-celle lymfom (DLBCL)