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| Name | Class |
|---|---|
| Fundamenta Therapeutics, Ltd. | INDUSTRY |
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This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | ThisCART19A,2×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused) |
|
| Dose Level 2 | Experimental | ThisCART19A,3×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART19A with Dose Level 1 | Drug | ThisCART19A,2×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16 |
| Measure | Description | Time Frame |
|---|---|---|
| BOR | Best Overall Response Rate | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 2 year |
| CR | Complete response rate | 2 year |
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Inclusion Criteria:
Voluntarily sign a documented IRB-approved ICF prior to any screening procedure;
Gender not restricted, 18 years ≤ age ≤ 75 years;
Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma;
Life expectancy ≥ 12 weeks at the time of enrollment;
Eastern Cooperative Oncology Group performance status score of 0 or 1;
At least one measurable lesion to be assessed, with any nodal lesion > 15mm in LDi (longest diameter) and any extranodal lesion > 10mm in LDi;
Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
CD19-positive lymphoma confirmed on a biopsy during screening.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Chen, M.D., Ph.D. | Contact | +86-512-67781856 | drchenjia@163.com | |
| Jun Li, Ph.D. | Contact | +86-18662604088 | jli@ctigen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
| ThisCART19A with Dose Level 2 | Drug | ThisCART19A,3×10^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16 |
|
|
| TTR |
Time to response |
| 3 month |
| DOR | Duration of response | 2 year |
| EFS | Event-free survival | 2 year |
| PFS | Progression-free survival | 2 year |
| OS | Overall survival | 2 year |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |