BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Phase 2 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2026
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Start
First participant enrolled
December 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
Study Completion
Last participant's last visit for all outcomes
February 1, 2031
August 18, 2026
August 1, 2026
4 years
August 11, 2026
August 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
24 Months
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.
24 months
Secondary Outcomes (5)
To determine the complete response rate.
24 Months
To determine the duration of response in patients with NHL and MM.
24 Months
To determine progression-free survival
24 Months
To determine the overall survival.
24 Months
To determine incidence of adverse events
24 Months
Study Arms (1)
LMY-920 Assessment
EXPERIMENTALParticipants will receive a single infusion of 4×10\^6 cells/kg of LMY-920 (autologous CAR-T cell therapy expressing the BAFF-ligand.)
Interventions
Single infusion of 4×10\^6 cells/kg of LMY-920 (autologous CAR-T cell therapy expressing the BAFF-ligand.)
Eligibility Criteria
You may qualify if:
- Histologically confirmed:
- a. B cell NHL (Including but not limited to diffuse large B cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior 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).
- iii. At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.
- OR b. MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
- ii. Measurable disease per IMWG uniform response criteria
- 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.
- Adequate organ function as defined by:
- Total bilirubin ≤ 1.5× institutional upper limit of normal (except in patients with Gilbert's syndrome, active hemolysis or disease involvement of the liver.)
- AST (SGOT)/ALT ≤ 2.5 × institutional upper limit of normal.
- Calculated creatinine clearance ≥ 30ml/min.
- Cardiac ejection fraction of ≥ 50%
- Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
- +3 more criteria
You may not qualify if:
- 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.
- Known active additional malignancies which require systemic treatment (non-immediately morbid malignancies receiving only low-toxicity regimens such as hormone suppression for prostate or breast cancer may be allowed at the judgment of the investigator.)
- Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
- Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event).
- Active infection requiring intravenous systemic treatment.
- HIV seropositivity.
- Pregnant or breastfeeding women are excluded from this study.
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
- Patients with history of active and clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
- Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- History of autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 2 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2026
First Posted
August 18, 2026
Study Start (Estimated)
December 1, 2026
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
February 1, 2031
Last Updated
August 18, 2026
Record last verified: 2026-08