RecruitingPhase 1NCT06916767

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Sponsor

Paolo Caimi, MD

Enrollment

18 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Refractory Lymphoma Relapsed CLL Refractory CLL

Summary

CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function. BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new type of cell therapy called BAFF CAR-T cells (LMY-920) in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding to standard treatments. CAR-T therapy involves modifying a patient's own immune cells to attack the cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CLL or SLL confirmed by biopsy - Your disease has relapsed after at least 2 prior treatment lines, including a BTK inhibitor (like ibrutinib) and a BCL2 inhibitor (like venetoclax) - You have active or measurable disease - Your general health status is acceptable (ECOG 0-2) **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid - Your general health is too poor to tolerate the treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.