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A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with B-NHL. It is planned to enroll 6-24 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cells( chimeric antigen receptor T cells) | Experimental | CT1190B cells infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR T cells | Drug | chimeric antigen receptor T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) after CT1190B infusion | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria | 12 months after CT1190B infusion |
| MTD and/or dose range | Evaluate Dose limited toxicity and recommended dosage range after CT0991 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 CT1190B 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 | |
|---|---|---|---|---|
| Kai Hu MD | Contact | 15010390336 | huk@gobroadhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Recruiting | Beijing | Beijing Municipality | 102200 | 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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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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The proportion of patients with complete response(CR) after CT1190B infusion
| 12 months after CT1190B 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 CT1190B infusion |
| Time to response (TTR) | The time from cell infusion to the first assessment of CR or PR | 12 months after CT1190B infusion |
| Time to complete response (TTCR) | The time from cell infusion to the first assessment of CR | 12 months after CT1190B infusion |
| Progression-free survival (PFS) | The time from the infusion of CT1190B cells to the first assessment of disease progression or death. | 12 months after CT1190B 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 CT1190B infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |