Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma

NCT05020392 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-25

No results posted yet for this study

Summary

This is a single-center, open-label and pragmatic clinical trial to evaluate the primary efficacy and safety of anti-CD19 chimeric antigen receptor (CAR)-modified T cells (CART-CD19) with concurrent BTK inhibitor in patients with relapsed or refractory B cell lymphoma

Conditions

Interventions

DRUG

BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells

BTK inhibitor from enrollment to more than 90 days after CAR-T-CD19 infusion. Fludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10\^6/kg on day 0 and day 1 respectively.

DRUG

Fludarabine-based chemotherapy + CAR-T-CD19 Cells

Fludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10\^6/kg on day 0 and day 1 respectively.

Sponsors & Collaborators

Wuhan Si'an Medical Technology Co., Ltd
collaborator UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER

Principal Investigators

Yu Hu · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation: NON_RANDOMIZED
Purpose: TREATMENT
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 70 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2021-09-14
Primary Completion: 2023-10-13
Completion: 2024-10-13
FDA Drug: Yes

Countries

China

Study Locations

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Entities

Diseases