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This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological malignancies.
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 1 | Experimental | Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19. |
|
| Experimental: 2 | Experimental | Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19. |
|
| Experimental: 3 | Experimental | Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19-CAR γδT | Biological | Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of each patient. | Adverse events of each patient will be recorded and analysed. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time of Anti-CD19 CAR γδT cells in vivo. | PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo. | 3 years |
| Antitumor Effects | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xie yanyun, master | Contact | +8615601041145 | yanyun_xie@doingtimes.com | |
| Li gangyi, master | Contact | +8613601204100 | gangyi_li@doingtimes.com |
| Name | Affiliation | Role |
|---|---|---|
| Li gangyi, master | Beijing Doing Biomedical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing DOING Biomedical Co., Ltd | Beijing | 100021 | 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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| Every 3 months post treatment up to 24 months |
| Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells. | Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells. | 4 weeks |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |