A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening
A Phase I Study of the In Vivo CAR-T Platform for Treating Advanced Malignant Tumors Based on Target Screening
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
50 participants
Nov 21, 2025
INTERVENTIONAL
Conditions
Summary
This is a single-arm, open-label, single-center, dose-escalation Phase I platform study designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of an in vivo CAR-T therapy (V001 Injection, targeting BCMA, GPRC5D, DLL3, etc.) in patients with advanced malignant tumors.
Eligibility
Inclusion Criteria7
- Age ≥ 18 years.
- Histologically confirmed advanced hematological malignancies (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that are relapsed or refractory.
- Tumor cells express the relevant target (e.g., BCMA, GPRC5D, DLL3) as required for the specific cohort.
- ECOG performance status 0-2 (hematological malignancies) or 0-1 (solid tumors) and life expectancy ≥ 3 months.
- Adequate organ function (e.g., creatinine clearance ≥45 mL/min, LVEF ≥45%).
- Patients of childbearing potential must agree to use effective contraception during the study and for 1 year after dosing.
- Signed informed consent form.
Exclusion Criteria9
- Active, uncontrolled infection.
- Active central nervous system metastases or involvement.
- Prior anticancer therapy, radiotherapy, or investigational therapy within specified timeframes before the first study dose.
- Severe cardiac or pulmonary disease (e.g., NYHA Class III/IV heart failure), severe hepatic or renal impairment.
- Active Hepatitis B, Hepatitis C, HIV, or syphilis infection.
- Prior allogeneic hematopoietic stem cell transplantation (within specified window) or active graft-versus-host disease.
- Pregnancy or lactation.
- History of severe allergy to any components of the investigational product.
- Any other condition deemed by the investigator to increase risk or interfere with study results.
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Interventions
An in vivo CAR-T drug targeting BCMA administered intravenously
An in vivo CAR-T drug targeting GPRC5D administered intravenously
An in vivo CAR-T drug targeting DLL3 administered intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07395479