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| Name | Class |
|---|---|
| Hebei Yanda Ludaopei Hospital | OTHER |
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This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ haematological malignancies.
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental:1 | Experimental | Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22. |
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| experimental:2 | Experimental | Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22. |
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| experimental:3 | Experimental | Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| :Anti-CD22-CAR | Biological | Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.) |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of each patient | Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 | 3 years |
| Survival time of Anti-CD22 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 |
| 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 |
| Maximum tolerated dose (MTD) of CD22 targeted CAR T cells. | Maximum tolerated dose (MTD) of CD22 targeted CAR T cells. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li xiangqun | Contact | 086-15712867910 | xiangqun_li@doingtimes.com |
| Name | Affiliation | Role |
|---|---|---|
| Li xiangqun | Kecellitics Biotech Company Ltd | Study Chair |
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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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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |