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A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cells( chimeric antigen receptor T cells) | Experimental | CT1190B-P and CT1192 cells infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric Antigen Receptor T Cells (CAR-T) | Drug | chimeric antigen receptor T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD and/or dose range | Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion | Up to 28 days after CAR-T cells infusion |
| Adverse Events (AE) after CT119X infusion | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria | 12 months after CT119X infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients with complete remission(CR)/partial response (PR) after CT119X 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 | |
|---|---|---|---|---|
| Aibin Liang MD,Ph.D. | Contact | +86 21 6611 1019 | lab7182@tongji.edu.cn | |
| Ping Li MD | Contact | +86 135 6418 1131 | lilyforever@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Aibin Liang MD,Ph.D. | Shanghai Tongji Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | Shanghai Municipality | 200065 | China |
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The proportion of patients with complete response(CR) after CT119X infusion
| 12 months after CT119X 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 CT119X infusion |
| Time to response (TTR) | The time from cell infusion to the first assessment of CR or PR | 12 months after CT119X infusion |
| Time to complete response (TTCR) | The time from cell infusion to the first assessment of CR | 12 months after CT119X infusion |
| Progression-free survival (PFS) | The time from the infusion of CT119X cells to the first assessment of disease progression or death. | 12 months after CT119X 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 CT119X infusion |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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