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OncoMatch/Clinical Trials/NCT05312801

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

Is NCT05312801 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BAFF CAR-T for lymphoma, non-hodgkin lymphoma, b-cell.

Phase 1RecruitingLuminary TherapeuticsNCT05312801Data as of May 2026

Treatment: BAFF CAR-TTherapy 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Must have received: systemic therapy

relapsed after 2 or more lines of therapy or disease refractory to chemotherapy

Cannot have received: autologous stem cell transplant

Exception: disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT)

disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT)

Cannot have received: autologous stem cell transplant

ASCT within 6 weeks of informed consent

Cannot have received: allogeneic hematopoietic stem cell transplantation

History of allogeneic hematopoietic stem cell transplantation

Cannot have received: investigational agent

Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection

Lab requirements

Kidney function

Serum creatinine < 1.5 mg/dL

Liver function

Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome); AST/ALT ≤ 2.5 X institutional upper limit of normal

Cardiac function

Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University Hospitals Seidman Cancer Center · Cleveland, Ohio
  • Taussig Cancer Institute | Cleveland Clinic · Cleveland, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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