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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Paolo Caimi, MD
Study ID
NCT06916767
Phase
PHASE1
Status
Recruiting
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Conditions

  • Refractory CLL
  • Refractory Lymphoma
  • Relapsed CLL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LMY-920 dose escalation

Primary Outcome Measure

Maximum tolerated dose of LMY-920 [ Time Frame: 28 days after the day of infusion (day 0) of LMY-920 or until death, whichever occurs first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Paolo Caimi, MD

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By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OH

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