LUMT1A22, Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Myeloma (LMY-920-002)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects must have histologically confirmed myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Failing line of therapy is defined accordingly to International Myeloma Workshop Consensus Panel.

• No evidence of CNS myeloma.

• Male or female \> 18 years of age.

• ECOG Performance status ≤ 2.

• Has measurable disease at the time of enrollment as defined by at least one of the following:

‣ Serum M-protein greater or equal to 0.5g/dL

⁃ Urine M-protein greater or equal to 200mg/24hr

⁃ Serum free light chain (FLC) assay: involved light chain greater or equal to 10mg/dL provided serum FLC ratio is abnormal

⁃ Bone marrow plasma cells greater than or equal to 30% total bone marrow cells

• \>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.

• Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).

• AST (SGOT)/ALT ≤ 2.5 X institutional upper limit of normal.

• Serum creatinine \< 2 mg/dL.

⁃ Cardiac ejection fraction of \>45%, and no evidence of pericardial effusion, as determined by an echocardiogram.

⁃ Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.

⁃ Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.

⁃ For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.

⁃ For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Locations
United States
Ohio
University Hospitals Seidman Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Leland Metheny, MD
Leland.Metheny@uhhospitals.org
(216) 844-0139
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 30
Treatments
Experimental: LMY-920 dose escalation
Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.
Related Therapeutic Areas
Sponsors
Collaborators: The Cleveland Clinic, Case Western Reserve University
Leads: Luminary Therapeutics

This content was sourced from clinicaltrials.gov

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