NCT06830031

Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma

A Phase 1 Study of C402-CD19-CAR, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Targeting CD19 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai Exuma Biotechnology Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.

Detailed description

This is a single-arm, open-label, phase 1 clinical study of C402-CD19-CAR cell therapy, to evaluate the safety, tolerability, efficacy of C402-CD19-CAR in subject with relapsed or refractory large B cell lymphoma. Subjects that meet inclusion criteria with positive CD19 (IHC ≥50% tumor cells or FACS ≥70% tumor cells) will receive C402-CD19-CAR treatment according to the modified 2+3+3 dose escalation design.

Conditions

• Diffuse Large B-cell-lymphoma
• DLBCL, Nos Genetic Subtypes
• Follicular Lymphoma Grade 3B
• PMBL
• HGBL With MYC and BCL2 and/or BCL6 Rearrangements
• HGBL, Nos

Interventions

Type	Name	Description
BIOLOGICAL	C402-CD19-CAR	Enrolled subjects will undergo apheresis to acquire peripheral blood mononuclear cells. C402-CD19-CAR will be generated from the subject's autologous T cells modified from the apheresis product. After C402-CD19-CAR production and product release, subjects will be administered with a single dose of C402-CD19-CAR via subcutaneous injection.

Timeline

• Start date: 2025-03-19
• Primary completion: 2026-03-09
• Completion: 2026-05-11
• First posted: 2025-02-17
• Last updated: 2025-06-13

Locations

1 site across 1 country: China