RecruitingPhase 1NCT06830031

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


Sponsor

Shanghai Exuma Biotechnology Ltd.

Enrollment

18 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing C402-CD19-CAR — a personalized cell therapy where a patient's own T cells are engineered to seek out and kill lymphoma cells carrying a protein called CD19 — for people with large B-cell lymphoma that has come back or stopped responding to prior treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with CD19-positive large B-cell lymphoma (such as DLBCL or grade 3b follicular lymphoma), confirmed by biopsy - Your lymphoma has relapsed (come back) or is refractory (no longer responding to treatment) - You are in reasonably good physical condition - You are willing and able to follow the study protocol **You may NOT be eligible if...** - Your lymphoma is CD19-negative - You have active central nervous system lymphoma - You have serious organ problems (heart, liver, or kidney) - You have active uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALC402-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.


Locations(1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

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NCT06830031


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