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A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1194C CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell NonHodgkin Lymphoma.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1194C cells in patients with B-NHL. It is planned to enroll 3-27 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cells chimeric antigen receptor T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T cells chimenric antigen receptor T cells | Drug | CT1194C cells infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) after CT1194C infusion | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria | 12 months after CT1194C infusion |
| MTD and/or dose range | Evaluate Dose limited toxicity and recommended dosage range after CT1194C infusion | Up to 28 days after CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients with complete remission(CR)/partial response (PR) after CT1194C infusion. | Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion |
| Complete response rate (CRR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Huang | Contact | 13971600192 | huangliang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Institute of Hematology and Blood Diseases Hospital | Tianjin | 300020 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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The proportion of patients with complete response(CR) after CT1194C infusion
| 12 months after CT1194C infusion |
| Duration of remission(DOR) | Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first. | 12 months after CT1194C infusion |
| Time to response (TTR) | The time from cell infusion to the first assessment of CR or PR | 12 months after CT1194C infusion |
| Time to complete response (TTCR) | The time from cell infusion to the first assessment of CR | 12 months after CT1194C infusion |
| Progression-free survival (PFS) | The time from the infusion of CT1194C cells to the first assessment of disease progression or death. | 12 months after CT1194C infusion |
| Overall survival (OS) | defined as the time from the date of receiving the infusion to the date of death from any cause | 12 months after CT1194C infusion] |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |