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Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT05633615 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (20)
California
- UC Irvine Health Cancer Center-Newport — Costa Mesa
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
- UCI Health Laguna Hills — Laguna Hills
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- UCSF Medical Center-Parnassus — San Francisco
Idaho
- Saint Luke's Cancer Institute - Boise — Boise
- Saint Luke's Cancer Institute - Fruitland — Fruitland
- Saint Luke's Cancer Institute - Meridian — Meridian
- Saint Luke's Cancer Institute - Nampa — Nampa
- Saint Luke's Cancer Institute - Twin Falls — Twin Falls
Arkansas
- Highlands Oncology Group - Fayetteville — Fayetteville
- University of Arkansas for Medical Sciences — Little Rock
- Highlands Oncology Group - Rogers — Rogers
- Highlands Oncology Group — Springdale
Arizona
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta
- Emory Saint Joseph's Hospital — Atlanta
Florida
- UF Health Cancer Institute - Gainesville — Gainesville
Illinois
- University of Illinois — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05633615
The ClinicalTrials.gov registry entry for NCT05633615 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05633615 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Idaho, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05633615 about?
NCT05633615 is a clinical study titled "Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma". 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 ...
What is the current status of trial NCT05633615?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2023-06-12. Estimated completion is 2030-06-30.
What conditions does trial NCT05633615 study?
This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal (Thymic) Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05633615?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Axicabtagene Ciloleucel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05633615?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05633615 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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