RecruitingPhase 1NCT07369492

Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma

A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma


Sponsor

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy targeting a protein called BAFF-R for adults with a rare and hard-to-treat form of B-cell lymphoma that lacks the CD19 protein — meaning standard CD19-targeting CAR-T therapies would not work for these patients. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory B-cell lymphoma that is confirmed to be CD19-negative - Your tumor tests positive for the BAFF-R protein - Your cancer failed to respond to or came back after at least two lines of prior treatment - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your lymphoma is CD19-positive (a different CAR-T therapy may be more appropriate) - Your tumor does not express the BAFF-R protein - Your organ function is too poor to tolerate CAR-T therapy - You have active central nervous system lymphoma - 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

BIOLOGICALBAFF-R CAR-T cells

BAFF-R CAR-T cells, single intravenous infusion


Locations(1)

Suzhou Hongci Hematology Hospital

Suzhou, China

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NCT07369492


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