BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies (NCT07679919)

🧪 Interventions in This Study

• LMY-922 (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 1\. Male or female 18-75 years of age. 2. Patient with: a. NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) 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), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma or b. CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:
2. 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.
3. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
4. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
5. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).
6. Disease-related symptoms as defined by any of the following:
7. Unintentional weight loss ≥10% within the previous 6 months.
8. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).
9. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.
10. Night sweats for ≥1 month without evidence of infection. or c. HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox. ii. Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) \<1 × 10\^3/mcL, Hb \<10g/dL, platelet count \<100 × 10\^3/mcL, leukemia cell count \>5 × 10\^3/mcL, symptomatic splenomegaly, or enlarging HCL mass \>2 cm in short axis. or d. MM: histologically confirmed 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 3. Adequate organ function as defined by:
11. Creatinine clearance more than or equal to 45 ml/min calculated by the Cockcroft - Gault formula
12. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Taussig Cancer Institute | Cleveland Clinic — Cleveland, Ohio

📞 Contact the Study Coordinator

Phone: (216) 445-4635

Email: CAIMIP@ccf.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.