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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Autologous CAR-T cell therapy expressing the BAFF-ligand.
Biological/VaccineLMY-920
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: LMY-920 dose escalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine recommended phase II dose of human LMY-920 in patients with relapsed or refractory myeloma.
Maximum tolerated dose
Time frame
24 monthsSecondary outcomes
1
To establish toxicity profile for the infusion of LMY-920.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. All adverse events during study will be collected, categorized, and graded. Attribution of relatedness to the investigational agent will be assigned.
Time frame
24 months2
To determine the objective response rate per International Myeloma Working Group uniform response criteria after treatment with LMY-920 in patients with relapsed or refractory myeloma.
Response rate.
Time frame
24 months3
To determine the complete response rate per International Myeloma Working Group uniform response criteria after treatment with LMY-920 in patients with relapsed or refractory myeloma.
Response rate.
Time frame
24 months4
To determine the duration of response.
Duration of response
Time frame
24 monthsSponsors and contacts
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Luminary Therapeutics
Lead sponsor
The Cleveland Clinic
Collaborator
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov