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| Name | Class |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
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This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR011 | Experimental | Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-CAR011 | Biological | Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety(Incidence of adverse events) | Incidence of adverse events (AEs) | 12 weeks |
| Objective response rate (ORR) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 12 months | |
| Duration of remission(DOR) | 12 months | |
| Progression free survival(PFS) |
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Inclusion Criteria:
Volunteered to participate in this study and signed informed consent
Age 18-70 years old, male or female
Relapsed or refractory B cell non-Hodgkin's lymphoma
1 Histologically diagnosed as DLBCL(including PMBCL) or follicular lymphoma(grade â…¢b) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (1st edition 2017)
2 Follicular lymphoma(stage â…¢-â…£)(grade â… -â…¢a)
3 Mantle cell lymphoma
All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)
At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
Expected survival ≥ 12 weeks
ECOG score 0-1
Adequate pulmonary, hepatic, renal and cardiac function
At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy therapy) prior to leukapheresis,or at least 4 weeks from monoclonal antibody therapy prior to CAR T infusion
No contraindications of leukapheresis
Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial
Exclusion Criteria:
Prior treatment with CAR T therapy or any other genetically modified T cell therapy
Relapse after allogeneic hematopoietic stem cell transplantation
Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people
Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
QT interval prolongation≥450 ms
A history of epilepsy or other central nervous system disorders
No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
The patient had a history of other primary cancers, with the following exceptions
Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
Used of systemic steroids within two weeks (using inhaled steroids is an exception)
Women who are pregnant or lactating or have breeding intent in 6 months
Participated in any other clinical trial within three months
The investigators believe that any increase in the risk of the subject or interference with the results of the trial
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aibin Liang, MD,Ph.D. | Contact | 0086-021-66111019 | lab7182@tongji.edu.cn | |
| Ping Li, MD,Ph.D. | Contact | 0086-021-66111015 | lilyforever76@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Shanghai Tongji Hospital, Tongji University School of Medicin | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
| 12 months |
| Overall survival(OS) | 12 months |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |