OncoMatch/Clinical Trials/NCT05633615
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Is NCT05633615 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for diffuse large b-cell lymphoma.
Treatment: Axicabtagene Ciloleucel · Cyclophosphamide · Fludarabine · Lisocabtagene Maraleucel · Mosunetuzumab · Polatuzumab Vedotin · Tisagenlecleucel — This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 CAR T-cell therapy candidate (FDA approved construct)
candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct
Performance status
ZUBROD 0–2
Prior therapy
Must have received: CAR-T cell therapy — planned
must be felt to be a candidate for CAR T-cell therapy with plans to be treated with FDA approved commercially available CD19 CAR T-cell construct
Cannot have received: bridging therapy with polatuzumab vedotin and/or mosunetuzumab (polatuzumab vedotin, mosunetuzumab)
Exception: permitted if not refractory or progression/relapse within 6 months of last infusion
participants must not receive polatuzumab vedotin, and/or mosunetuzumab as part of bridging therapy
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^3/uL (no myeloid growth factor within 72 hours); Platelets ≥ 75 x 10^3/uL (no platelet transfusion within 72 hours)
Kidney function
Creatinine clearance ≥ 40 mL/min, as estimated by the Cockcroft and Gault formula
Liver function
Total bilirubin ≤ 2 x institutional ULN (unless due to Gilbert's disease or lymphomatous involvement of liver); AST and ALT ≤ 3 x institutional ULN
Cardiac function
Ejection fraction ≥ 40%; NYHA class 2B or better; no MI and PCI within 6 months or MI without PCI within 3 months, or unstable angina
Total bilirubin ≤ 2 x institutional ULN (unless due to Gilbert's disease or lymphomatous involvement of liver); AST and ALT ≤ 3 x institutional ULN; Creatinine clearance ≥ 40 mL/min; Ejection fraction ≥ 40%; NYHA class 2B or better; ANC ≥ 1.0 x 10^3/uL; Platelets ≥ 75 x 10^3/uL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Loyola University Medical Center · Maywood, Illinois
- University of Iowa/Holden Comprehensive Cancer Center · Iowa City, Iowa
- University of Kansas Cancer Center · Kansas City, Kansas
- University of Kansas Cancer Center-Overland Park · Overland Park, Kansas
- University of Kansas Hospital-Westwood Cancer Center · Westwood, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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