BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies (NCT07679919) | Clinical Trial Compass
Not Yet RecruitingPhase 1
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies
United States27 participantsStarted 2026-09
Plain-language summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, 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 hematologic malignancies, 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 refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Cutoff levels of Hb \<10 g/dL or platelet counts \<100 × 10\^9/L are generally regarded as indication for treatment.
. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
. Disease-related symptoms as defined by any of the following:
. Unintentional weight loss ≥10% within the previous 6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on figuring out a safe dose of LMY-922 rather than proving it works, what does that mean for my personal risk compared to the potential benefit at this stage?
2This trial isn't recruiting yet — given where my disease is right now, is it worth waiting for it to open, or are there other treatment options I should be pursuing in the meantime?
3LMY-922 is a CAR-T cell therapy targeting BAFF, which is different from other CAR-T approaches — can you explain how this mechanism might or might not make sense for my specific diagnosis, whether that's my NHL, CLL, or myeloma?
4Since this trial is specifically for refractory disease, meaning treatments have already stopped working, does my current treatment history actually fit what this trial is looking for, and are there standard options I haven't tried yet that might come first?
5CAR-T cell therapies can involve serious side effects like cytokine release syndrome — given that Phase 1 trials are still establishing the safe dose range, what monitoring and support would be in place if I were eventually enrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety profile of LMY-922 in patients with refractory hematologic malignancies.
Timeframe: 12 Months
2
To determine the Recommended Phase II Dose of LMY-922 in patients with refractory hematologic malignancies.
. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).
. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.
Exclusion criteria
. Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
. Renal failure requiring regular dialysis.
. Uncontrolled pulmonary disease or infection.
. 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) within 6 months prior to registration.
. Active infection requiring systemic treatment.
. HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies/mL.
. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.
. 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.)