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This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC-19PD1 CAR-T Cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC-19PD1 CAR-T cells | Biological | T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events | Percentage of participants with adverse events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| objective remission rate | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR) | 3 months |
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Inclusion Criteria:
(1)CD19 positive B-cell lymphoma; (2)Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; (3)At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; (4)18 to 70 Years Old, Male and female; (5)Expected to survive for more than 3 months; (6)Clinical performance status of ECOG score 0-1; (7)Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; (8)hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.
(9)INR≤ 1.5times normal range; APTT≤ 1.5times normal range; (10)Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; (11)Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaoting Zhang, PhD | Contact | 86-010-88196768 | zhangchaoting1@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |