Clinical trial · Interventional
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
NCT07395479CI-TRIAL-00111449recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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,FcRH5, etc.) in patients with advanced malignant tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumours | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| V001-BCMA | Genetic | — | UNRESOLVED |
| V001-DLL3 | Genetic | — | UNRESOLVED |
| V001-FcRH5 | Genetic | — | UNRESOLVED |
| V001-GPRC5D | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- V001-BCMA
- description
- 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.
- interventionNames
- Genetic: V001-BCMA
- type
- EXPERIMENTAL
- label
- V001-GPRC5D
- description
- 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.
- interventionNames
- Genetic: V001-GPRC5D
- type
- EXPERIMENTAL
- label
- V001-DLL3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.