Phase 1 Study of LMY-920 (BAFF CAR-T Cells) for Relapsed/Refractory CLL/SLL
This study is testing a new treatment called LMY-920, which are special immune cells (BAFF CAR-T cells) designed to fight certain blood cancers. It's for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or hasn't responded to at least two other treatments, including specific types of inhibitors. Before receiving LMY-920, participants will get other medications called Obinutuzumab, Cyclophosphamide, and Fludarabine. The main goal is to find the safest dose of LMY-920. This study is looking for about 18 participants and its current recruitment status is unclear.
- Study design
- This is an interventional study with an enrollment of 18 participants. It is a single-arm study, meaning all participants receive the same treatment.
- What's involved
- Participants will receive a single infusion of LMY-920. They will also receive Obinutuzumab, Cyclophosphamide, and Fludarabine before the LMY-920 infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose of LMY-920 will be measured for 28 days after the infusion or until death, whichever comes first.
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NCT06916767
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentPaolo Caimi, MDInvestigator-initiated
~18 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:BAFF CAR-TObinutuzumabCyclophosphamideFludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose of LMY-920
Measured over 28 days after the day of infusion (day 0) of LMY-920 or until death, whichever occurs first
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Paolo Caimi, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Relapsed after 2 or more lines of therapy, including a BTK inhibitor and a BCL2 inhibitor. 2. No evidence of CNS lymphoma. 3. Male or female ≥ 18 years of age. 4. ECOG Performance status ≤ 2 \[See Appendix 1\]. 5. Presence of Presence of active disease for participants with CLL and SLL and presence of measurable disease for participants with SLL.
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 × 109/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.
Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).
Disease-related symptoms as defined by any of the following:
Unintentional weight loss ≥10% within the previous 6 months.
Significant fatigue (ie, ECOG performance scale 2 or worse; cannot work or unable to perform usual activities).
Fevers ≥100.5°F or 38.0°C for 2 or more weeks without evidence of infection.
Night sweats for ≥1 month without evidence of infection. B. Measurable disease for participants with SLL: At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma. 6. \>2 weeks since prior radiation therapy or 5 half-lives for systemic therapy at the time of leukapheresis, whichever is shorter (Note: Obinutuzumab pre-treatment of CLL/SLL participants must start at the latest 14 days prior to apheresis). 7. Total bilirubin ≤ 1.5 X upper institutional limit of normal (except in participants with Gilbert's syndrome, active hemolysis or disease involvement of the liver). 8. AST (SGOT)/ALT ≤ 2.5 X institutional upper limit of normal. 9. Calculated creatinine clearance ≥ 30ml/min. 10. Cardiac ejection fraction of ≥50% 11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air. 12. Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document. 13. 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 90 days after the BAFF CAR-T cell infusion.
Exclusion
Participants will undergo a pre-lymphodepletion safety check in the 48h preceding lymphodepletion with Fludarabine and Cyclophosphamide. The objective of these criteria is to avoid infusion in participants with acutely heightened risk of toxicity.
Participants must continue to meet eligibility criteria prior to initiation of lymphodepletive chemotherapy, with exception of the absolute lymphocyte count. This eligibility re-check will be done up to 48 hours prior to initiation of lymphodepletion.
Symptoms, signs or laboratory markers of active infection or systemic inflammatory response.
Symptoms, signs or laboratory markers of an uncontrolled medical condition, including but not limited to decompensation of cardiac or pulmonary conditions. These changes exclude symptoms, signs or laboratory markers of disease progression, as long eligibility criteria are met.
Total bilirubin ≤ 2 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 times normal) or of non - hepatic origin.
AST (SGOT) and ALT (SGPT) ≤ 4 X institutional upper limit of normal
Serum Creatinine ≤ 2 X the institutional upper limit of normal
Participants must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
Absence of clinical signs, symptoms, or laboratory markers of cardiac dysfunction.
Use of corticosteroids within 2 days prior to day 0 infusion, with the exception of agents used for prevention of emesis during lymphodepletive chemotherapy.
Neurologic symptoms suggestive of an active central nervous system condition.
Signs or laboratory markers of active infection or systemic inflammatory response.
Signs or laboratory markers of active infection or systemic inflammatory response.
Participants with fever over 38.2 degrees Celsius (detected in 2 separate measurements separated by at least 15 minutes)
Delay and re-conditioning (if delay is longer than 48 hours) can be considered in participants who have resolution of their symptoms.
What this trial measures
- Maximum tolerated dose of LMY-92028 days after the day of infusion (day 0) of LMY-920 or until death, whichever occurs first