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Two drugs, mosunetuzumab and polatuzumab vedotin, either alone or in combination, to treat diffuse large B-cell lymphoma (DLBCL), grade 3b follicular lymphoma or primary mediastinal large B-cell lymphoma (PMBCL) that has come back (relapsed) or not gotten better with treatment (refractory) after CAR T-cell therapy

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18 and older

Phase 2

76 Locations

NCT05633615

Clinical Trial Goal


To find out  if mosunetuzumab and polatuzumab vedotin are safe and work well to treat DLBCL, grade 3b follicular lymphoma or PMBCL that has relapsed or is refractory after CAR T-cell therapy

You may be able to join this trial if you:


  • Are 18 years or older
  • Have any of the following that has relapsed or is refractory:
    • DLBCL
    • Grade 3b follicular lymphoma 
    • PMBCL
  • Are able to receive CAR T-cell therapy. Your doctor can tell you this
  • Do not have lymphoma in your brain or spinal cord
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells. 
Cyclophosphamide and fludarabine are drugs that block the growth of cancer cells.
Mosunetuzumab is a T-cell engaging bispecific antibody that target CD20 and CD3 on certain cells.
Polatuzumab vedotin is a monoclonal antibody-drug conjugate, or combination, that targets CD79b on certain cells.

To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
 
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
  • Cyclophosphamide – Given as intravenous (IV) infusions 
  • Fludarabine – Given as IV infusions 

Then, the CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.

You'll then be randomized to 1 of 3 groups. Once you’re randomized, you’ll be told what group you’re in:
  • Group 1 – Mosunetuzumab
  • Group 2 – Polatuzumab vedotin
  • Group 3 – Mosunetuzumab plus polatuzumab vedotin

Randomized means doctors will use a computer to assign you to a group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You’ll get:
  • MosunetuzumabGroup 1 and 3 only - Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Polatuzumab vedotin –  Group 2 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been

You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years. 

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat DLBCL, grade 3b follicular lymphoma or PMBCL that has relapsed or is refractory after CAR T-cell therapy is new and unproven.

Contacts


Erin Rogers, 210-614-8808, erogers@swog.org

Dana Sparks, 210-614-8808, dsparks@swog.org

Locations

Banner University Medical Center - TucsonRECRUITING

Tucson, Arizona
Site Public Contact, UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North CampusRECRUITING

Tucson, Arizona
Site Public Contact, UACC-IIT@uacc.arizona.edu

Highlands Oncology GroupRECRUITING

Springdale, Arkansas
Site Public Contact, 479-872-8130, research@hogonc.com

Highlands Oncology Group - FayettevilleRECRUITING

Fayetteville, Arkansas
Site Public Contact, 479-872-8100, research@hogonc.com

Highlands Oncology Group - RogersRECRUITING

Rogers, Arkansas
Site Public Contact, 479-872-8130, research@hogonc.com

University of Arkansas for Medical SciencesRECRUITING

Little Rock, Arkansas
Site Public Contact, 501-686-8274

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareRECRUITING

Irvine, California
Site Public Contact, 877-827-8839, ucstudy@uci.edu

UC Irvine Health/Chao Family Comprehensive Cancer CenterRECRUITING

Orange, California
Site Public Contact, 877-827-8839, ucstudy@uci.edu

UCSF Medical Center-ParnassusRECRUITING

San Francisco, California
Site Public Contact, 877-827-3222

University of Florida Health Science Center - GainesvilleRECRUITING

Gainesville, Florida
Site Public Contact, 352-273-8010, cancer-center@ufl.edu

Emory Saint Joseph's HospitalRECRUITING

Atlanta, Georgia
Site Public Contact, 404-851-7115

Emory University Hospital/Winship Cancer InstituteRECRUITING

Atlanta, Georgia
Site Public Contact, 404-778-1868

Saint Luke's Cancer Institute - BoiseRECRUITING

Boise, Idaho
Site Public Contact, 208-381-2774, eslinget@slhs.org

Saint Luke's Cancer Institute - FruitlandRECRUITING

Fruitland, Idaho
Site Public Contact, 208-381-2774, eslinget@slhs.org

Saint Luke's Cancer Institute - MeridianRECRUITING

Meridian, Idaho
Site Public Contact, 208-381-2774, eslinget@slhs.org

Saint Luke's Cancer Institute - NampaRECRUITING

Nampa, Idaho
Site Public Contact, 208-381-2774, eslinget@slhs.org

Saint Luke's Cancer Institute - Twin FallsRECRUITING

Twin Falls, Idaho
Site Public Contact, 208-381-2774, eslinget@slhs.org

Loyola University Medical CenterRECRUITING

Maywood, Illinois
Site Public Contact, 708-226-4357

University of Chicago Comprehensive Cancer CenterRECRUITING

Chicago, Illinois
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

University of IllinoisRECRUITING

Chicago, Illinois
Site Public Contact, 312-355-3046

University of Iowa/Holden Comprehensive Cancer CenterRECRUITING

Iowa City, Iowa
Site Public Contact, 800-237-1225

University of Kansas Cancer CenterRECRUITING

Kansas City, Kansas
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

University of Kansas Cancer Center-Overland ParkRECRUITING

Overland Park, Kansas
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer CenterRECRUITING

Westwood, Kansas
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

The James Graham Brown Cancer Center at University of LouisvilleRECRUITING

Louisville, Kentucky
Site Public Contact, 502-562-3429

UofL Health Medical Center NortheastRECRUITING

Louisville, Kentucky
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu

Johns Hopkins University/Sidney Kimmel Cancer CenterRECRUITING

Baltimore, Maryland
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

Henry Ford Health Providence Southfield HospitalACTIVE_NOT_RECRUITING

Southfield, Michigan

Ascension Borgess Cancer CenterRECRUITING

Kalamazoo, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Bronson Battle CreekRECRUITING

Battle Creek, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Bronson Methodist HospitalRECRUITING

Kalamazoo, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Cancer and Hematology Centers of Western Michigan - Norton ShoresRECRUITING

Norton Shores, Michigan
Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org

Corewell Health Grand Rapids Hospitals - Butterworth HospitalRECRUITING

Grand Rapids, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterRECRUITING

Saint Joseph, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles HospitalRECRUITING

Niles, Michigan
Site Public Contact, 616-391-1230

Corewell Health Reed City HospitalRECRUITING

Reed City, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Munson Medical CenterRECRUITING

Traverse City, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids HospitalRECRUITING

Grand Rapids, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Trinity Health Muskegon HospitalRECRUITING

Muskegon, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

University of Michigan Health - WestRECRUITING

Wyoming, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

Wayne State University/Karmanos Cancer InstituteRECRUITING

Detroit, Michigan
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

Weisberg Cancer Treatment CenterRECRUITING

Farmington Hills, Michigan
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

West Michigan Cancer CenterRECRUITING

Kalamazoo, Michigan
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

University of New Mexico Cancer CenterRECRUITING

Albuquerque, New Mexico
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRECRUITING

New York, New York
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

NYP/Weill Cornell Medical CenterRECRUITING

New York, New York
Site Public Contact, 212-746-1848

University of RochesterRECRUITING

Rochester, New York
Site Public Contact, 585-275-5830

Wilmot Cancer Institute at WebsterRECRUITING

Webster, New York
Site Public Contact, WCICTOresearch@urmc.rochester.edu

Carolinas Medical Center/Levine Cancer InstituteRECRUITING

Charlotte, North Carolina
Site Public Contact, 800-804-9376

Duke University Medical CenterRECRUITING

Durham, North Carolina
Site Public Contact, 888-275-3853

Wake Forest University Health SciencesRECRUITING

Winston-Salem, North Carolina
Site Public Contact, 336-713-6771

Case Western Reserve UniversityRECRUITING

Cleveland, Ohio
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

University of Oklahoma Health Sciences CenterRECRUITING

Oklahoma City, Oklahoma
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

Oregon Health and Science UniversityRECRUITING

Portland, Oregon
Site Public Contact, 503-494-1080, trials@ohsu.edu

Providence Newberg Medical CenterRECRUITING

Newberg, Oregon
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

Providence Portland Medical CenterRECRUITING

Portland, Oregon
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

Providence Saint Vincent Medical CenterRECRUITING

Portland, Oregon
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

Providence Willamette Falls Medical CenterRECRUITING

Oregon City, Oregon
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

Geisinger Medical CenterRECRUITING

Danville, Pennsylvania
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

Geisinger Wyoming Valley/Henry Cancer CenterRECRUITING

Wilkes-Barre, Pennsylvania
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

University of Pennsylvania/Abramson Cancer CenterRECRUITING

Philadelphia, Pennsylvania
Site Public Contact, 855-216-0098, PennCancerTrials@careboxhealth.com

Medical University of South CarolinaRECRUITING

Charleston, South Carolina
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

Prisma Health Cancer Institute - ButternutRECRUITING

Greenville, South Carolina
Site Public Contact, 864-241-6251

Prisma Health Cancer Institute - EasleyRECRUITING

Easley, South Carolina
Site Public Contact, 864-522-2066, Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - EastsideRECRUITING

Greenville, South Carolina
Site Public Contact, 864-241-6251

Prisma Health Cancer Institute - FarisRECRUITING

Greenville, South Carolina
Site Public Contact, 864-241-6251

Prisma Health Cancer Institute - GreerRECRUITING

Greer, South Carolina
Site Public Contact, 864-241-6251

Prisma Health Cancer Institute - SenecaRECRUITING

Seneca, South Carolina
Site Public Contact, 864-241-6251

Prisma Health Cancer Institute - SpartanburgRECRUITING

Boiling Springs, South Carolina
Site Public Contact, 864-241-6251

Baptist Memorial Hospital and Cancer Center-MemphisRECRUITING

Memphis, Tennessee
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

University of Vermont Medical CenterRECRUITING

Burlington, Vermont
Site Public Contact, 802-656-4101, rpo@uvm.edu

Virginia Commonwealth University/Massey Cancer CenterRECRUITING

Richmond, Virginia
Site Public Contact, CTOclinops@vcu.edu

Froedtert and MCW Moorland Reserve Health CenterRECRUITING

New Berlin, Wisconsin
Site Public Contact, 414-805-0505

Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin
Site Public Contact, 414-805-3666

University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterRECRUITING

Madison, Wisconsin
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University HospitalRECRUITING

Madison, Wisconsin
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

ClinicalTrials.gov record


NCT05633615. First posted on 12/1/22

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