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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BAFF CAR-T
DrugAutologous CAR-T cell therapy expressing the BAFF-ligand.
Treatment groups
20 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.
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 .
Response rate.
Time frame
24 months3
To determine the complete response rate.
Response rate.
Time frame
24 months4
To determine the duration of response.
Duration of response.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Luminary Therapeutics
Lead sponsor
Case Comprehensive Cancer Center
Collaborator
Source ClinicalTrials.gov