LMY-920 for Treatment of Relapsed or Refractory Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuminary Therapeutics
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
ASCT within 6 weeks of informed consent.
History of allogeneic hematopoietic stem cell transplantation.
Active graft-versus-host disease.
Active central nervous system or meningeal involvement by myeloma. Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.
Trial design
Treatments tested in this trial
- Autologous CAR-T cell therapy expressing the BAFF-ligand.
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Luminary Therapeutics
Lead sponsor
The Cleveland Clinic
Collaborator
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov