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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 (May 2026). This Phase 2 trial studies Relmacabtagene autoleucel (relma-cel) for b-cell non hodgkin lymphoma.

Phase 2RecruitingRuijin HospitalNCT06365671Data as of May 2026

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

Cancer type

Hodgkin Lymphoma

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.

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