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Non-Hodgkin Lymphoma Refractory/ RelapsedPhase 2NCT07771361

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

A Phase 2 study testing BAFF CAR-T in people with Non-Hodgkin Lymphoma Refractory/ Relapsed and Multiple Myeloma Refractory, run by Luminary Therapeutics.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAFF CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Dec 2026to Feb 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed:
  • 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).
  • 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.
  • Measurable disease per IMWG uniform response criteria
  • No evidence of CNS lymphoma.
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  • 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.
  • Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after the BAFF CAR-T cell infusion.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with a failure rate of < 1% per year during the treatment period , and agreement to refrain from donating spermfor at least 6 months after the BAFF CAR-T cell infusion.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Carolyn Odom contact

‪612-444-5789‬

carolyn@luminarytx.com

About this study

Official title: Phase 2 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)

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.

Read the detailed description

LMY-920 is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate malignant B cells.

BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on non-Hodgkin lymphoma and multiple myeloma.

The goal of the Phase 2 LMY-920-004 study is to establish the safety profile of LMY-920 and to determine the objective response rate.

Being tested
BAFF CAR-T
Keywords
Multiple Myeloma, Non-Hodgkin Lymphoma, Refractory, Relapsed, CAR-T, B-cell, Lymphoma, Neoplasms, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
Medical subject headings
Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphoma, Recurrence, Neoplasms, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAFF CAR-TBiological

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

Study groups in NCT07771361
Study groupRoleWhat they receive
LMY-920 AssessmentExperimentalParticipants will receive a single infusion of 4×10^6 cells/kg of LMY-920 (autologous CAR-T cell therapy expressing the BAFF-ligand.)
Receives: Biological: BAFF CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 24 months

Secondary outcomes (5)

  1. To determine the complete response rate.

    Complete Response Rate

    Measured: 24 Months

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

    Duration of Response

    Measured: 24 Months

  3. To determine progression-free survival

    Progression-free Survival

    Measured: 24 Months

  4. To determine the overall survival.

    Overall survival.

    Measured: 24 Months

  5. To determine incidence of adverse events

    Incidence of adverse events.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single dose.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771361
Sponsor's protocol ID
LMY-920-004
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAFF CAR-T in people with Non-Hodgkin Lymphoma Refractory/ Relapsed and Multiple Myeloma Refractory, run by Luminary Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carolyn Odom (‪612-444-5789‬, carolyn@luminarytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of LMY-920 in patients with relapsed or refractory B-cell NHL and MM. (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07771361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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