Health Trials

BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma and Multiple Myeloma

ConditionsNon-Hodgkin Lymphoma Refractory/ RelapsedMultiple Myeloma RefractoryMultiple Myeloma in RelapseNon-Hodgkin Lymphoma, B-cellNon-Hodgkin LymphomaNon-Hodgkin Lymphoma (NHL)Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaMultiple Myeloma in Remission
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuminary Therapeutics

About this trial

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma, 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 lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.

This Phase 2 study will establish the safety and efficacy profile of LMY-920.

Eligibility criteria

Qualifiers

No evidence of CNS lymphoma.

Participant is ≥ 18 years of age.

ECOG Performance status ≤ 2.

> 2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis. Patients with mantle cell lymphoma that can only remain stable with continuation of prior BTK inhibitor may continue these agents up to 48 hours prior to apheresis.

Disqualifiers

ASCT within 6 weeks prior to informed consent.

History of allogeneic transplantation.

Active graft-versus-host disease.

Active central nervous system or meningeal involvement by lymphoma or leukemia. 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 enrollment.

Trial design

Treatments tested in this trial

  • BAFF CAR-T

Treatment groups

90 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Luminary Therapeutics

Lead sponsor

Source ClinicalTrials.gov