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。
This study intends to combine CD30 CAR-T (provided by Wuhan Bio-Raid Biotechnology Co., Ltd) and Camrelizumab (provided by Jiangsu Hengrui Pharmaceutical Co., Ltd.) to treat r/r CD30+ lymphoma, to observe the safety and effectiveness of the combined treatment, and to study the effect of PD-1 antibody on the pharmacokinetics and pharmacodynamics of CAR-T. Obtain a better treatment plan and provide a new strategy for the treatment of clinically r/r CD30+ lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Received Camrelizumab treatment on the 15th day after CAR-T cell reinfusion, and then received Camrelizumab treatment every 2 weeks.
Department of Hematology Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGoverall response rate
including complete remission (CR) or partial remission (PR)
Time frame: up to 3 months after CAR-T cell infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the safety of camrelizumab combined with CD30 CAR-T in the treatment of relapsed/refractory CD30+ lymphoma.
Time frame: up to 90 days
overall survival (OS)
The time from the day of enrollment to death due to any cause. If it is unclear whether the subject has died, OS refers to the duration from the day of enrollment to the date of the last follow-up.
Time frame: 24 months
Duration of remission (DOR)
Defined as the time between the initial appearance of complete or partial remission for a subject in objective remission to the appearance of disease recurrence or death from any cause (whichever occurs first).
Time frame: 24 months
Progression-free Survival (PFS)
The time from the start of the trial to the day of PD or to death due to any reason. If the subject's disease status is unclear, PFS refers to the duration from the day of enrollment to the date of the last follow-up.
Time frame: 24 months
Time to Remission (TTR).
The time from the first day of medication to the first assessment of PR or CR, whichever comes first. Only applicable to subjects with CR or PR.
Time frame: 12 months
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