Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuminary Therapeutics
About this trial
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, 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 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Eligibility criteria
Qualifiers
Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).
No evidence of central nervous system (CNS) lymphoma.
Male or female > 18 years of age.
Eastern Cooperative Oncology Group 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 lymphoma or leukemia.
Trial design
Treatments tested in this trial
- BAFF CAR-T
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Luminary Therapeutics
Lead sponsor
Case Comprehensive Cancer Center
Collaborator
Source ClinicalTrials.gov