Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma

Recruiting now · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin Lymphoma, B-Cell

In brief

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, 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 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.

Key facts

Study ID

NCT05312801

Run by

Luminary Therapeutics

People needed

20

Starts

2023-11-21

Expected to finish

2025-09-02

Last updated by the study team

2024-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to 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).
• No evidence of central nervous system (CNS) lymphoma.
• Male or female > 18 years of age.
• Eastern Cooperative Oncology Group Performance status ≤ 2.
• At least one measurable lesion.
• >2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.
• Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).
• Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal.
• Serum creatinine < 1.5 mg/dL.
• Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram.
• 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 90 days after the BAFF CAR-T cell infusion.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.

You may not qualify if…

• ASCT within 6 weeks of informed consent.
• History of allogeneic hematopoietic stem cell transplantation.
• Active graft-versus-host disease.
• Active central nervous system or meningeal involvement by lymphoma or leukemia.
• Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
• Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
• New York Heart Association class IV congestive heart failure.
• Cardiovascular disorders including 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 intravenous systemic treatment.
• HIV seropositivity.
• Pregnant or breastfeeding women.
• 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 with history of 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.
• Known additional malignancies which require systemic treatment.
• History of autoimmune disease with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.

Where it is running

• Taussig Cancer Institute | Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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