Status:
RECRUITING
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
Lead Sponsor:
Luminary Therapeutics
Collaborating Sponsors:
Case Comprehensive Cancer Center
Conditions:
Lymphoma, Non-Hodgkin Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 posi...
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 engi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05312801
Start Date
November 21 2023
End Date
September 2 2025
Last Update
October 21 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
2
Taussig Cancer Institute | Cleveland Clinic
Cleveland, Ohio, United States, 44195