Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma
NCT05320081 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-04-11
Summary
The is a phase II, single-arm, open-label clinical study assessing the efficacy and safety of Camrelizumab combined with CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 30 subjects with r/r CD30+ lymphoma。
Conditions
- Lymphoma
- Relapse/Recurrence
Interventions
- BIOLOGICAL
-
CD30 CAR-T
Subjects need to complete a series of checks before reinfusion of CD30 CAR-T cells as baseline information for subjects after non-myeloablative pretreatment. The subject was reinfused with CD30 CAR-T cells (10±3)×10\^6/kg on the 0th day of the first dosing cycle (the investigator decided the specific reinfusion dose based on the subject's own/disease conditions and preparation conditions in vitro ), concurrent oxygen inhalation and monitoring (ECG, blood pressure and blood oxygen monitoring). The reinfusion was completed in about 30 minutes, and the tube was flushed with saline. Note: CAR-T cell infusion and reinfusion dose are based on the subject's condition.
- DRUG
-
Camrelizumab
Received Camrelizumab treatment on the 15th day after CAR-T cell reinfusion, and then received Camrelizumab treatment every 2 weeks.
Sponsors & Collaborators
-
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Jianfeng Zhou · Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-30
- Primary Completion
- 2023-12-31
- Completion
- 2024-06-30
Countries
- China
Study Locations
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