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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 (Jun 2026). This Phase 1 trial studies BAFF CAR-T for lymphoma, non-hodgkin lymphoma, b-cell.

Phase 1RecruitingLuminary TherapeuticsNCT05312801Data as of Jun 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

Treatments studied

Other

BAFF CAR-T

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 →

Frequently asked questions

Is NCT05312801 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior autologous stem cell transplant, autologous stem cell transplant, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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