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This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified anti-CD19 CAR T cell therapy | Experimental | CAR T cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified anti-CD19 CAR T cells | Biological | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events [Safety and Tolerability] | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Up to 5 years after modified CD19 CAR-T cells infusion |
| Dose-limiting toxicity (DLT) | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after modified CD19 CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| B-cell malignancies, Overall response rate(ORR) | Assessment of ORR(ORR=CR+PR) | 3 months, 6 months |
| B-cell malignancies, Overall survival | From the first infusion of modified CD19 CAR-T cells to death or the last visit |
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Inclusion Criteria:
Male or female aged 18-70 years;
Estimated survival time ≥ 12 weeks;
Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
At least one assessable tumor lesion;
ECOG performance status 0 to 2;
Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| pei shu, MD | Contact | +86(028)85423525 | peishu1991@sina.com | |
| fuchun guo, MD | Contact | +86(028)85423525 | FCguo0797@wchscu.cn |
| Name | Affiliation | Role |
|---|---|---|
| liqun zou, phd | Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to 2 years after modified CD19 CAR-T cells infusion |
| B-cell malignancies, progression-free survival(PFS) | From the first infusion of modified CD19 CAR-T cells to the occurrence of any event, including death, relapse, disease progression, and the last visit | Up to 2 years after modified CD19 CAR-T cells infusion |
| B-cell malignancies, disease control rate (DCR) | Assessment of DCR(DCR=CR+PR+SD) | Month 6,12,18 and 24 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |