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CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19/CD22 CAR-T group | Experimental | Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19-CAR-T cell was 2×10e6/kg and CD22-CAR-T cell was 1×10e6/kg. Both CAR-T cells were infused at the same day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19/CD22-bispecific CAR-T cells | Drug | CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best ORR | Overall response rate means sum of complete response rate and partial response rate | From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Best CR rate | CR was defined as complete remission evaluated using PET-CT scan or BM test | From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liang Wang | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason
| From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion |
| overall survival (OS) | OS was defined from the date of CAR-T infusion to the date fo death | From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| 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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