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| Name | Class |
|---|---|
| Novatim Immune Therapeutics (Zhejiang) Co., Ltd. | INDUSTRY |
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This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | CD19/CD22-CAR-transduced T cells at escalating doses (0.5~5.0 ×10^6 cells/kg) |
|
| Dose expansion | Experimental | CD19/CD22-CAR-transduced T cells at MTD or highest dose administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells) | Biological | CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-limiting toxicity | Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 28 days |
| Incidence and severity of adverse events | Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Proportion of patients achieving a response | up to 15 years |
| Progression free survival | Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
(B-NHL)
a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijing Zhang | Contact | 021-64175590 | 88503 | JJYIN555@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanchang University; | Recruiting | Nanchang | Jiangxi | 360000 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| up to 15 years |
| Overall survival | Overall survival (OS) will be determined as the time from the start of the preparative regimen until death | up to 15 years |
| MRD negative response rates( Acute Lymphoblastic Leukemia ) | MRD status post infusion,MRD will be performed utilizing flow cytometry or PCR. | up to 15 years |
| Persistence of CD19/CD22 CAR-T cells blood, bone marrow | pk properties of CD19/CD22 CAR-T | up to 15 years |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |