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

NCT06916767 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-10

No results posted yet for this study

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.

Conditions

  • Relapsed CLL
  • Refractory CLL
  • Refractory Lymphoma

Interventions

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

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Paolo Caimi, MD

    lead OTHER

Principal Investigators

  • Paolo Caimi, MD · Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06916767 on ClinicalTrials.gov