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Clinical Trial NCT07395479 for Advanced Malignant Tumours is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening Early Phase 1 50 Open-Label
Clinical Trial NCT07395479 is designed to study Treatment for Advanced Malignant Tumours. It is a Early Phase 1 interventional study that is recruiting, having started on 21 November 2025, with plans to enroll 50 participants. Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, it is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 9 February 2026.
Brief 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.
Detailed Description
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.) based on a lentiviral vector platform in patients with advanced malignant tumors (including hematological malignancies and solid tumors). The s...Show More
Official Title
A Phase I Study of the In Vivo CAR-T Platform for Treating Advanced Malignant Tumors Based on Target Screening
Conditions
Advanced Malignant TumoursOther Study IDs
- NCC5276
NCT ID Number
Start Date (Actual)
2025-11-21
Last Update Posted
2026-02-09
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
in vivo CAR-T
DLL3
GPRC5D
BCMA
DLL3
GPRC5D
BCMA
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalV001-BCMA Intravenous administration of V001-BCMA as a single agent for patients with B-cell-related hematologic malignancies. Dose cohorts: 1x10\^8 TU、2x10\^8 TU、≤4x10\^8 TU and ≤8x10\^8 TU. | V001-BCMA An in vivo CAR-T drug targeting BCMA administered intravenously |
ExperimentalV001-GPRC5D Intravenous administration of V001-GPRC5D as a single agent for patients with B-cell-related hematologic malignancies. Dose cohorts: 1x10\^8 TU、2x10\^8 TU、≤4x10\^8 TU and ≤8x10\^8 TU. | V001-GPRC5D An in vivo CAR-T drug targeting GPRC5D administered intravenously |
ExperimentalV001-DLL3 Intravenous administration of V001-BCMA as a single agent for patients with small cell lung cancer. Dose cohorts: 1x10\^8 TU、2x10\^8 TU、≤4x10\^8 TU and ≤8x10\^8 TU. | V001-DLL3 An in vivo CAR-T drug targeting DLL3 administered intravenously |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of Dose-Limiting Toxicities (DLTs) | Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion. | Within 28 days after the first infusion |
Maximum Tolerated Dose (MTD) | To determine the MTD of V001 Injection. | During the dose-escalation phase (approximately 12 months) |
Incidence of Adverse Events (AEs) | Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0. | From signing ICF until 24 months after the last infusion. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate (ORR) | Best overall response rate assessed per indication-specific criteria. | At Day 28, Months 2, 3, 6, 9, 12, 18, 24 post-infusion |
Duration of Response (DOR) | Time from first achieving response to disease progression or death. | From date of the first response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Progression-Free Survival (PFS) | From date of infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | From date of infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Overall Survival (OS) | Time from infusion to death from any cause | From the date of infusion until the date of death from any cause, assessed up to 24 months |
Peak concentration of CAR-T cells in peripheral blood | Peak concentration of CAR-T cells in peripheral blood | At multiple timepoints post-infusion up to Month 24 |
time to peak of CAR-T cells in peripheral blood | time to peak of CAR-T cells in peripheral blood | At multiple timepoints post-infusion up to Month 24 |
AUC of CAR-T cells in peripheral blood | AUC of CAR-T cells in peripheral blood | At multiple timepoints post-infusion up to Month 24 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Cancer Institute and Hospital, Chinese Academy of Medical SciencesStudy Central Contact
Contact: Li Ning, M.D., +86 01087788165, [email protected]
Contact: Shuhang Wang, PhD, +86 01087788165, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District, Beijing, Beijing Municipality, 100021, China
Ning Li, Contact, +86010-87788165, [email protected]
Recruiting