Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Objectives: * Primary

Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 3. Participant Intervention: * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged between 15 and 75 years old, regardless of gender;

• Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;

• Expected survival time of ≥ 3 months;

• Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;

• Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;

• No severe heart, lung, liver, or kidney diseases;

• Capable of understanding and willing to sign the informed consent form for this trial;

• No contraindications to peripheral blood apheresis for the subject;

⁃ Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;

⁃ The subject must have received standard first- and second-line treatment regimens;

⁃ Not having received antibody-based drug treatment within 2 weeks before cell therapy.

Locations
Other Locations
China
Shenzhen University General Hospital
RECRUITING
Shenzhen
Contact Information
Primary
lixin wang
wanglixin1991@sohu.com
0755-21839999
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Experimental: CART group
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Shenzhen University General Hospital

This content was sourced from clinicaltrials.gov

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