LMY-920 for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Taussig Cancer Institute | Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Seidman Cancer Center
NOT_YET_RECRUITING
Cleveland
Contact Information
Primary
Paolo F. Caimi, MD
CAIMIP@ccf.org
216 445-4635
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-09-02
Participants
Target number of participants: 20
Treatments
Experimental: LMY-920 dose escalation
Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.
Related Therapeutic Areas
Sponsors
Leads: Luminary Therapeutics
Collaborators: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov