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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR066 | Experimental | Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD20-directed CAR-T cells with CliniMACS Prodigy® system | Biological | Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The incidence of treatment-emergent adverse events (TEAEs) | Up to 12 weeks after C-CAR066 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The percentage of subjects who achieved complete response and partial response | Up to 24 months after C-CAR066 infusion |
| Complete response rate (CRR) | The percentage of subjects who achieved complete response |
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Inclusion Criteria:
Exclusion Criteria:
Have a history of allergy to cellular products
Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
Patients with active CNS involvement
Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
Live vaccination within 4 weeks before apheresis
HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
Have a history of alcoholism, drug addiction and mental illness
Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
Patients with severe fludarabine or cyclophosphamide hypersensitivity
The patient has a history of other primary cancers, except for the following:
The investigators believe that there are other circumstances that are not suitable for the trial
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| Name | Affiliation | Role |
|---|---|---|
| Aibin Liang, MD,Ph.D. | Shanghai Tongji Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Shanghai | 200065 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39351902 | Derived | Li P, Liu W, Zhou L, Ye S, Zhu D, Huang J, Li J, Zheng C, Zhu S, Yao X, Zhu K, Yao Y, Qiu L, Liang A, Zou D. C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. Am J Hematol. 2024 Dec;99(12):2306-2312. doi: 10.1002/ajh.27488. Epub 2024 Oct 1. |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Up to 24 months after C-CAR066 infusion |
| Duration of response (DOR) | The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion | Up to 24 months after C-CAR066 infusion |
| Progression free survival (PFS) | The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death | Up to 24 months after C-CAR066 infusion |
| Overall survival (OS) | Time from C-CAR066 infusion to death from any cause | Up to 24 months after C-CAR066 infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |