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| Name | Class |
|---|---|
| Peking University Shenzhen Hospital | OTHER |
| Chengdu Military General Hospital | OTHER |
| iCAR Bio Therapeutics Ltd. | INDUSTRY |
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This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CARvac T cells | Experimental | CD19 CARvac T cells transduced with a lentiviral vector to express |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CARvac T cells | Biological | CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 28 days | |
| Type of dose-limiting toxicity (DLT) | 28 days | |
| Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies | 1 year |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Pinz | Contact | 6315386218 | kevin.pinz@icellgene.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongyu Zhang, MD, PhD | Peking University Shenzhen Hospital | Principal Investigator |
| Fang Liu, MD, PhD | The General Hospital of Western Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Western Theater Command | Recruiting | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32840736 | Derived | Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available. |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 1 year |
| Overall survival | 1 year |
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |