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| Name | Class |
|---|---|
| Nanjing Enricnk Biotech Co., Ltd | UNKNOWN |
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A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10^8 cells, 1×10^9 cells, 1.5×10^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD19 CAR NK cells | Experimental | CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 CAR NK cells | Biological | Patients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Doses of 6×10^8, 1×10^9, 1.5×10^9 Anti-CD19 CAR NK cells will infused in each group using the "3 + 3" dose-escalation strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLTs) | To characterize the safety, tolerability, and determine the Maximum tolerated dose (MTD) of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma. | within 4 weeks after infusion |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | To characterize the safety of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma | up to 48 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate (ORR) | To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory diffuse large B cell lymphoma | 1, 3, 6 and 12 months after infusion |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
Relapsed after allogenic haemopoietic stem cell transplantation (HSCT).
Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cell infusion.
Subjects with acquired and congenital immunodeficiency diseases.
Subjects with grade III or IV heart failure (NYHA classification).
History of epilepsy or other central nervous system (CNS) diseases.
Subjects with extranodal lymphoma in Intracranial, lung, or gastrointestinal tract.
History of other primary malignant tumors except:
Systemic corticosteroids are used concomitantly within 2 weeks prior to treatment.
Females who are pregnant, lactating, or planning a pregnancy within six months.
Subjects who have received other clinical trial treatment within 3 months.
Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Yang, Ph. D. | Contact | 13918735105 | chyangjianmin@163.com | |
| Libing Wang, Ph.D. | Contact | 13918735105 | doctorwanglibing@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.
| 1, 3, 6, 12 and 12 months after infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |