Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability | 24 weeks | |
| MTD of universal dual specificity CD19 and CD20 or CD22 CAR-T cells | The highest dose of universal dual specificity CD19 and CD20 or CD22 CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of universal dual s | 4 weeks |
| Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six-month Objective response rate of complete remission and partial remission | 24 weeks | |
| Six-month Overall survival | 24 weeks | |
| Six-month Progression free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenying Zhang | Contact | 86-10-55499341 | zhangwenying.1984@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 weeks |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
Not provided
Not provided