BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Luminary Therapeutics
Study ID
NCT07679919
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LMY-922 — BIOLOGICAL
    Allogeneic CAR-T cell therapy expressing the BAFF-ligand

Study Details

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory hematologic malignancies, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-Hodgkin Lymphoma: LMY-922 Dose Level -1
    Dose Level -1 of 75 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Non-Hodgkin Lymphoma: LMY-922 Dose Level 1
    Dose Level 1 of 150 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Non-Hodgkin Lymphoma: LMY-922 Dose Level 2
    Dose Level 2 of 300 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Non-Hodgkin Lymphoma: LMY-922 Dose Level 3
    Dose Level 3 of 450 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level -1
    Dose Level -1 of 75 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 1
    Dose Level 1 of 150 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 2
    Dose Level 2 of 300 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 3
    Dose Level 3 of 450 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Multiple Myeloma: LMY-922 Dose Level -1
    Dose Level -1 of 75 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Multiple Myeloma: LMY-922 Dose Level 1
    Dose Level 1 of 150 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Multiple Myeloma: LMY-922 Dose Level 2
    Dose Level 2 of 300 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.
  • Experimental: Multiple Myeloma: LMY-922 Dose Level 3
    Dose Level 3 of 450 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design.

Primary Outcome Measure

To assess the safety profile of LMY-922 in patients with refractory hematologic malignancies. [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Taussig Cancer Institute | Cleveland ClinicClevelandOhio44195
Paolo F Caimi, MD
[email protected]
216 445-4635
Cancer Answer line
866-223-8100

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