OncoMatch/Clinical Trials/NCT05260957
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
Is NCT05260957 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAR-T Cell Therapy and Mosunetuzumab for refractory non-hodgkin lymphoma.
Treatment: Mosunetuzumab · Polatuzumab · CAR-T Cell Therapy — The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline-based chemotherapy — primary refractory
failure to obtain any response (PR or CR) after at least 3 cycles of anthracycline-based therapy or persistent disease after 6 cycles of anthracycline-based therapy
Must have received: cytarabine-based chemotherapy — primary refractory (MCL)
In case of mantle cell lymphoma, the primary therapy if does not include an anthracycline, should include either high doses of cytarabine +/-bendamustine and an anti-CD20 antibody (usually rituximab).
Must have received: platinum-based chemotherapy — relapsed
Relapsed disease that fails to respond (CR or PR) after at least 2 cycles of a platinum and/or cytarabine-based chemotherapy.
Must have received: autologous stem cell transplant — relapse after transplant
Relapse after an autologous stem cell transplantation. At least 3 months should have lapsed between autologous stem cell infusion and initiation of pre-CAR-T lymphodepleting chemotherapy
Cannot have received: anti-CD19 CAR-T cell therapy
Previous anti-CD19 CAR-T therapy is not allowed.
Lab requirements
Blood counts
Absolute neutrophil count >1000/microliter, Hg> 8 grams/ deciliter, Absolute lymphocyte count >250/microliter, Platelet count >75,000/microliter
Kidney function
creatinine clearance as measured by the Cockcroft-Gault equation should be 50 mL/min or better (CrCl ≥ 50 mL/min)
Liver function
Unless the patient has a known Gilbert syndrome, the total Bilirubin should be less that 1.5 x upper limit of normal (ULN) and both the transaminases (ALT and AST) should be less than 2.5 x ULN. The only exception to this rule is lymphoma infiltration of the liver where values of total Bilirubin up to 3 x ULN and transaminases up to 5 x ULN will be allowed after communication with the Principal Investigator
Cardiac function
ejection fraction of the left ventricle as estimated on Echocardiogram or MUGA scan should be at least 45% (LVEF ≥ 45%)
See inclusion criteria 7-11
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
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