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CAR T cells (CB-010) to treat B-cell non-Hodgkin lymphoma (NHL) that has come back (relapsed) or has not gotten better with treatment (refractory)

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18 and older

Phase 1

31 Locations

NCT04637763

Clinical Trial Goal


To find out:
  • The highest dose of CB-010 that's safe to give
  • If CB-010 is safe and works well to treat B-cell NHL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have B-cell NHL that has relapsed or is refractory. Some examples include:
    • Burkitt lymphoma
    • Chronic lymphocytic leukemia (CLL)
    • Diffuse large B-cell lymphoma (DLBCL)
    • Follicular lymphoma
    • Mantle cell lymphoma (MCL)
    • Small lymphocytic lymphoma (SLL)
  • Have not been treated with therapy that targets CD19 on certain cells. Your doctor can tell you this
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) 
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cyclophosphamide and fludarabine are drugs that block the growth of cancer cells.
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. CB-010 is a type of CAR T-cell therapy that targets CD19 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, using a technique called CRISPR, 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 CB-010 is 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.

The clinical trial doctors will watch you closely over the first 24 hours. 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 some types of CAR T-cell therapy to treat B-cell NHL. The FDA has not yet approved CB-010.

Watch a video about CAR T-Cell Therapy

Contacts


Socorro Portella, MD, 973 866 7567, clinicaltrials@cariboubio.com

Locations

University of Alabama at BirminghamTERMINATED

Birmingham, Alabama

Banner MD Anderson Cancer CenterRECRUITING

Gilbert, Arizona
Tracy Kliner, 480-256-4739, tracy.kliner@bannerhealth.com

HonorHealthRECRUITING

Scottsdale, Arizona
Research Nurse Navigator, 480-323-1364, clinicaltrials@honorhealth.com

University of Arizona Cancer CenterRECRUITING

Tucson, Arizona
Francois Chu, 520-621-0823, fchu@arizona.edu

University of ArkansasRECRUITING

Little Rock, Arkansas
Dr. Cesar Gentille Sanchez, 501-686-8274, cgentille@uams.edu

Chao Family Comprehensive Cancer Center/University of California IrvineRECRUITING

Orange, California
Blake Johnson, 714-456-3476, blakej@hs.uci.edu

University of California San Diego Moores Cancer CenterRECRUITING

La Jolla, California
Michelle Padilla, 858-822-5223, mlp002@health.ucsd.edu

University of Southern California, Norris Comprehensive Cancer CenterRECRUITING

Los Angeles, California
Christine Duran, 323-865-0371, Duran_c@med.usc.edu

Advent HealthRECRUITING

Orlando, Florida
Kristen Wing, 407-303-8251, Kristen.Wing@adventhealth.org

Bone and Marrow Transplant Group of GeorgiaRECRUITING

Atlanta, Georgia
Melhem Solh, MD, 404-255-1930, msolh@bmtga.com

Georgia Cancer Center at Augusta UniversityRECRUITING

Augusta, Georgia
Kelly Jenkins, 706-721-1206, kejenkins@augusta.edu

Holden Comprehensive Cancer Center at the University of IowaRECRUITING

Iowa City, Iowa
Umar Farooq, 319-384-8044, umar-farooq@uiowa.edu

Norton Cancer InstituteRECRUITING

Louisville, Kentucky
Tabby Thomas, 502-899-3366, StudyStartup@NCIResearch.org

University of Kentucky Markey CancerRECRUITING

Lexington, Kentucky
Yvonne Taul, 859-323-7628, Yvonne.Taul@uky.edu

Tufts Medical CenterRECRUITING

Boston, Massachusetts
LaToya Marshall, 617-636-5409, latoya.marshall@tuftsmedicine.org

Atlantic Health SystemRECRUITING

Morristown, New Jersey
Contacts:

Hackensack Medical CenterRECRUITING

Hackensack, New Jersey
Elizabeth McCarthy, 412-860-6447, elizabethl.mccarthy@hmhn.org

Montefiore Medical CenterRECRUITING

The Bronx, New York
Joel Victor, 718-430-8761, jovictor@montefiore.org

Nyu Langone HealthRECRUITING

New York, New York
MARK BOND, 646-754-7217, Mark.Bond@nyulangone.org

Oncology Hematology CareRECRUITING

Cincinnati, Ohio
Eric Clayton, 513-751-2273, Eric.Clayton@usoncology.com

Ohio State University James Cancer HospitalTERMINATED

Columbus, Ohio

Oregon Health & Science UniversityRECRUITING

Portland, Oregon
Richard Maziarz, MD, 503-494-6345, MAZIARZR@ohsu.edu

University of PennsylvaniaRECRUITING

Philadelphia, Pennsylvania
Contacts:

Vanderbilt University Medical CenterRECRUITING

Nashville, Tennessee
Dr. Olalekan Oluwole, 615-936-8422, olalekan.oluwole@vanderbilt.edu

Baylor Charles A. Sammons Cancer CenterRECRUITING

Dallas, Texas
Tarah Satterfield, 214-818-8472, Tarah.Satterfield@BSWHealth.org

MD Anderson Cancer CenterRECRUITING

Houston, Texas
Ly Dsouza, 713-745-8614, ldsouza@mdanderson.org

Huntsman Cancer Institute at the University of UtahRECRUITING

Salt Lake City, Utah
Erin Peterson, 801-587-4655, erin.peterson@hci.utah.edu

Virginia Commonwealth University (VCU)RECRUITING

Richmond, Virginia
Kristin Lantis, 804-628-2341, kllantis@vcu.edu

Virginia Oncology AssociatesRECRUITING

Norfolk, Virginia
Karen McClain, 757-466-8683, Karen.mcclain@usoncology.com

Swedish Cancer InstituteTERMINATED

Seattle, Washington

Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin
Roisin McAndrew, 414-805-5447, rmcandrew@mcw.edu

ClinicalTrials.gov record


NCT04637763. First posted on 11/20/20

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