ClinicalTrials.gg
Not yet recruitingNCT07771361Updated Aug 18, 2026

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

A Phase 2 interventional study of BAFF CAR-T in Non-Hodgkin Lymphoma Refractory/ Relapsed, Multiple Myeloma Refractory and Multiple Myeloma in Relapse, sponsored by Luminary Therapeutics. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Primary conditionLymphoma, B-CellRegistry: Lymphoma, Non-HodgkinReclassifiedWhy we changed it
Registry
Lymphoma, Non-Hodgkin — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, B-Cell
Why
  1. The study's listed conditions name Lymphoma, B-Cell, a narrower term within Lymphoma, Non-Hodgkin.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Luminary Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Non-Hodgkin Lymphoma Refractory/ Relapsed
  • Multiple Myeloma Refractory
  • Multiple Myeloma in Relapse
  • Non-Hodgkin Lymphoma, B-cell
  • Non-Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma (NHL)
  • Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
  • Multiple Myeloma in Remission

Keywords

  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Refractory
  • Relapsed
  • CAR-T
  • B-cell
  • Lymphoma
  • Neoplasms
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
03

In context

Lymphoma, B-Cell Reclassified

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

This study's planned enrollment of 90 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

Luminary Therapeutics is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Compared within Lymphoma, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphoma, Non-Hodgkin. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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. after 2 or more , 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 stem cell transplantation (ASCT).

    iii. At least one 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

  2. No evidence of CNS lymphoma.
  3. Participant is ≥ 18 years of age.
  4. Performance status ≤ 2.
  5. > 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.
  6. Adequate organ function as defined by:

    1. Total ≤ 1.5× institutional (except in patients with Gilbert's syndrome, active hemolysis or disease involvement of the liver.)
    2. (SGOT)/ALT ≤ 2.5 × institutional upper limit of normal.
    3. Calculated ≥ 30ml/min.
    4. Cardiac of ≥ 50%
    5. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
  7. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written document.
  8. For women of : agreement to remain abstinent (refrain from heterosexual intercourse) or use a 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.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. within 6 weeks prior to .
  2. History of allogeneic transplantation.
  3. Active .
  4. Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated /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.
  5. Known active additional 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.)
  6. Less than 28 days elapsed between prior treatment with agent(s) and the day of lymphocyte collection.
  7. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, myocardial infarction or stroke (including , or other ischemic event).
  8. Active infection requiring intravenous systemic treatment.
  9. seropositivity.
  10. Pregnant or breastfeeding women are excluded from this study.
  11. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow prior to initiation of therapy.
  12. Serologic status reflecting active or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
  13. 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.
  14. Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  15. History of disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of medications (other than low dose ) within 2 months.
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    LMY-920 Assessment

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

    Biological: BAFF CAR-T

Interventions

  • BiologicalBAFF CAR-T

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

06

What researchers measure

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

  5. To determine incidence of adverse events

    Incidence of adverse events.

    Time frame: 24 Months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.

Of 122 phase 2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 77. This study's planned 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 18, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2030
CompletionEst.
Feb 2031
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07771361
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Feb 2031 (estimated)
Last update
Aug 18, 2026

Study contacts

Carolyn Odom
Contact
carolyn@luminarytx.com
‪612-444-5789‬

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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