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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BAFF CAR-T

    Biological/Vaccine

    Single infusion of 4×10\^6 cells/kg of LMY-920 (autologous CAR-T cell therapy expressing the BAFF-ligand.)

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: LMY-920 AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the efficacy of LMY-920 in patients with relapsed or refractory B-cell NHL and MM.

Determine the objective response rate per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with LMY-920 in patients with relapsed or refractory NHL, and per International Myeloma Working Group (IMWG) uniform response criteria in patients with relapsed or refractory MM.

Time frame
24 Months
2

To assess the safety of LMY-920 in patients with relapsed or refractory B-cell NHL and MM.

Number of participants with treatment-related adverse events as assessed by CTCAE v6.0. All adverse events during study will be collected, categorized, and graded. Attribution of relatedness to the investigational agent will be assigned.

Time frame
24 months

Secondary outcomes

1

To determine the complete response rate.

Complete Response Rate

Time frame
24 Months
2

To determine the duration of response in patients with NHL and MM.

Duration of Response

Time frame
24 Months
3

To determine progression-free survival

Progression-free Survival

Time frame
24 Months
4

To determine the overall survival.

Overall survival.

Time frame
24 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luminary Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: