NCT06916767

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Paolo Caimi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is a persistent need for development of new, effective therapies for treatment of B cell malignancies. Therapy with CAR-T cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. While CAR T-cells have activity against CLL/SLL, the rates of response are more limited than non Hodgkin lymphoma. Based on preclinical data of anti BAFF-R CAR T-cells13 as well as preclinical and early phase studies using anti-BAFF-R monoclonal antibodies in CLL) investigators posit that CAR-T cells expressing BAFF (BAFF CAR-T cells, LMY-920 can become another strategy to treat refractory CLL. This study will evaluate the safe dose and provide initial signal of the activity of BAFF CAR- T cells against relapsed CLL/SLL using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process that can be replicated in multiple academic institutions with the appropriate cellular manufacturing facilities.

Conditions

• Relapsed CLL
• Refractory CLL
• Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	BAFF CAR-T	Single infusion
DRUG	Obinutuzumab	IV administered
DRUG	Cyclophosphamide	500mg/m2 on days -5 to -3
DRUG	Fludarabine	30mg/m2 daily on days -5 to -3

Timeline

• Start date: 2025-07-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-04-08
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study