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OncoMatch/Clinical Trials/NCT06365671

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Is NCT06365671 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Relmacabtagene autoleucel (relma-cel) for b-cell non hodgkin lymphoma.

Phase 2RecruitingRuijin HospitalNCT06365671Data as of Jun 2026Location: China

Treatment: Relmacabtagene autoleucel (relma-cel)Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

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Extracted eligibility criteria

Treatments studied

Other

Relmacabtagene autoleucel (relma-cel)

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Allowed: TP53 alterations

Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations

Allowed: MYC rearrangement

high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement

Allowed: BCL2 rearrangement

high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement

Allowed: BCL6 rearrangement

high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement

Performance status

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

Prior therapy

Min 1 prior line

Must have received: anti-CD20 monoclonal antibody

individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen

Must have received: anthracycline

individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen

Cannot have received: autologous stem cell transplant

History of autologous or allogeneic stem cell transplantation

Cannot have received: allogeneic stem cell transplant

History of autologous or allogeneic stem cell transplantation

Cannot have received: CAR-T cell therapy targeting CD19

Prior chimeric antigen receptor cellular immunotherapy targeting CD19

Lab requirements

Kidney function

Serum creatinine ≤1.5 ULN, or creatinine clearance ≥ 30 mL/min

Liver function

ALT/AST ≤ 3 ULN; total bilirubin ≤1.5 mg/dL (<3x ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)

Cardiac function

Cardiac ejection fraction ≥ 40%

Adequate renal and hepatic function defined as: Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN); Total bilirubin ≤1.5 mg/dL(<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma); Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min; Cardiac ejection fraction ≥ 40%

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

Frequently asked questions

Is NCT06365671 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior autologous stem cell transplant, allogeneic stem cell transplant, CAR-T cell therapy targeting CD19 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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