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This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional therapy | No Intervention | patients accept conventional radioactive and chemical therapy. | |
| anti-CD19 anti-CD20 Bispecific CAR-T | Experimental | patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 anti-CD20 Bispecific CAR-T | Biological | patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Effects | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. | Every 3 months post treatment up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo. | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. | 3 years |
| Adverse events of each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gai liyun | Contact | 086-13269099630 | liyun_gai@doingtimes.com | |
| li gangyi | Contact | 086-13901106501 | gangyi_li@doingtimes.com |
| Name | Affiliation | Role |
|---|---|---|
| li gangyi | Beijing Doing Biomedical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Sanhe | Hebei | 065200 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
| 3 years |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |