NCT05020392

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

Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

Anti-CD19 chimeric antigen receptor (CAR) T-cell has shown dramatical efficacy in B cell malignancies. And Bruton tyrosine kinase (BTK) inhibitor agents have been validated as an effective drug to treat B cell malignancies. Combined therapies comprising ibrutinib (a BTK inhibitor) and anti-CD19 CAR-T cells in patients with CLL after ibrutinib failure are considered feasible and safe. Ibrutinib is the first-generation BTK inhibitror and Zanubrutinib is the second-generation BTK inhibitor. Orelabrutinib is a newly developed BTK inhibitor with high selectivity and have received its approval in China. Autologous cells derived T cells are purified and transduced with a lentiviral vector encoding the humanized CD19 scFv. To evaluate whether the addition of BTK inhibitor (Ibrutinib, Zanubrutinib and Orelabrutinib) in anti-CD19 CAR-T cells therapy would further improve efficacy and safety, we intend to conduct this pragmatic clinical trial.

Conditions

• Diffuse Large B Cell Lymphoma
• Burkitt Lymphoma
• Follicular Lymphoma
• Chronic Lymphocytic Leukemia
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2023-10-13
• Completion: 2024-10-13
• First posted: 2021-08-25
• Last updated: 2023-07-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study