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 (Jun 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
Treatments studied
Immunotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05260957 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD19 CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages