NCT04215016

Safety of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Diffuse Large B-cell Lymphoma

A Single-arm, Open-label, Dose Escalation Study to Explore Safety, Efficacy and Pharmacokinetics of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose escalation, phase I study, aiming to evaluate the safety and efficacy of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific Chimeric Antigen Receptor (CAR) T-cells in patient with relapsed or refractory diffuse B cell lymphoma.

Detailed description

CD19 CAR-T cell therapy has made breakthroughs in the treatment of B cell lymphoma and leukemia, but 30% of patients still have antigen escape, which may be related to variants in tumor cells and the expansion of CD19-negative tumor cells after treatment with CD19 CAR-T cells. CD19/CD20 bispecific CAR-T cell targeting multiple antigens can attack tumor cells while overcoming tumor antigen escape caused by a single target, maximizing efficacy and duration of treatment, and can also solve the problem of uneven distribution or low expression of single target on the tumor surface.

Conditions

• Relapsed or Refractory DLBCL Patients With Either CD19 or CD20 Positive

Interventions

Type	Name	Description
BIOLOGICAL	Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells	Humanized anti-CD19 and CD20 bispecific autologous CAR-T cells injection: the first dose is 1.0×106 /kg, the second dose is 3.0×106 /kg, and the third dose is 8.0×106 /kg. Patients will receive lymphodepleting chemotherapy at least 1 week before CAR-T cell infusion.

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-01-02
• Last updated: 2020-01-02

Locations

1 site across 1 country: China