MedTrace Logo

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

NCT06830031 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-13

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    collaborator OTHER

  • Shanghai Exuma Biotechnology Ltd.

    lead INDUSTRY

Principal Investigators

  • Liang Huang, MD · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2026-03-09
Completion
2026-05-11

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830031 on ClinicalTrials.gov