Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma

Sponsor
Huazhong University of Science and Technology
Study ID
NCT05320081
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CD30 CAR-T — BIOLOGICAL
    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.
  • Camrelizumab — DRUG
    Received Camrelizumab treatment on the 15th day after CAR-T cell reinfusion, and then received Camrelizumab treatment every 2 weeks.

Study Details

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。

Key Dates

Start date
Nov 30, 2021
Status verified
Apr 2022
Primary completion
Dec 31, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab combined with CD30 CAR-T
    This study have only one arm that is Camrelizumab combined with CD30 CAR-T experimental arm.

Primary Outcome Measure

overall response rate [ Time Frame: up to 3 months after CAR-T cell infusion ]

Central Contacts

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