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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.
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 study employs a platform design, enrolling patients into different cohorts based on target and indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V001-BCMA | Experimental | 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-GPRC5D | Experimental | 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-DLL3 | Experimental | 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-FcRH5 | Experimental | Intravenous administration of V001-FcRH5 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V001-BCMA | Genetic | An in vivo CAR-T drug targeting BCMA administered intravenously |
| |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine levels | Pharmacodynamic Biomarkers | At multiple timepoints post-infusion up to Month 24 |
| CRP | Pharmacodynamic Biomarkers | At multiple timepoints post-infusion up to Month 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Ning, M.D. | Contact | +86 01087788165 | lining@cicams.ac.cn | |
| Shuhang Wang, PhD | Contact | +86 01087788165 | wangshuhang@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuhang Wang, PhD | Clinical Trial Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| V001-GPRC5D |
| Genetic |
An in vivo CAR-T drug targeting GPRC5D administered intravenously |
|
| V001-DLL3 | Genetic | An in vivo CAR-T drug targeting DLL3 administered intravenously |
|
| V001-FcRH5 | Genetic | An in vivo CAR-T drug targeting FcRH5 administered intravenously |
|
| 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 |
| Ferritin | Pharmacodynamic Biomarkers | At multiple timepoints post-infusion up to Month 24 |
| Immunogenicity | Incidence of anti-drug antibodies. | Baseline, Day 28, Months 3, 6, 9, 12 |