Print

Purpose

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age greater than or equal to 18 at the time of enrollment - Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care - Eastern Cooperative Oncology Group performance status 0 or 1 - Adequate hematologic, renal, liver, cardiac and pulmonary organ function

Exclusion Criteria

  • Prior therapy with an anti-CD19 targeting agent - Active or chronic graft versus host disease requiring therapy - Prior allogeneic stem cell transplantation - Central nervous system (CNS) lymphoma, prior CNS malignancy - Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement. - Primary immunodeficiency - Current or expected need for systemic corticosteroid therapy - Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted - Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence - Unwillingness to follow extended safety monitoring

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
The CB10A clinical study consists of (Part A) 3 + 3 design with three dose levels. (Part B) Expansion portion patients will receive CB-010 at the dose determined in Part A.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation of CB-010 		Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
  • Genetic: CB-010
    CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
Experimental
Expansion of CB-010 		Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
  • Genetic: CB-010
    CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
Contact:
Tracy Kliner
480-256-4739
tracy.kliner@bannerhealth.com

HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
Contact:
Research Nurse Navigator
480-323-1364
clinicaltrials@honorhealth.com

University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85724
Contact:
Francois Chu
520-621-0823
fchu@arizona.edu

University of Arkansas
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Dr. Cesar Gentille Sanchez
501-686-8274
cgentille@uams.edu

University of California San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92073
Contact:
Michelle Padilla
858-822-5223
mlp002@health.ucsd.edu

University of Southern California, Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90089
Contact:
Christine Duran
323-865-0371
Duran_c@med.usc.edu

Chao Family Comprehensive Cancer Center/University of California Irvine
Orange 5379513, California 5332921 92868
Contact:
Blake Johnson
714-456-3476
blakej@hs.uci.edu

Advent Health
Orlando 4167147, Florida 4155751 32803
Contact:
Kristen Wing
407-303-8251
Kristen.Wing@adventhealth.org

Bone and Marrow Transplant Group of Georgia
Atlanta 4180439, Georgia 4197000 30342
Contact:
Melhem Solh, MD
404-255-1930
msolh@bmtga.com

Georgia Cancer Center at Augusta University
Augusta 4180531, Georgia 4197000 30912
Contact:
Kelly Jenkins
706-721-1206
kejenkins@augusta.edu

Holden Comprehensive Cancer Center at the University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Umar Farooq
319-384-8044
umar-farooq@uiowa.edu

University of Kentucky Markey Cancer
Lexington 4297983, Kentucky 6254925 40536
Contact:
Yvonne Taul
859-323-7628
Yvonne.Taul@uky.edu

Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40207
Contact:
Tabby Thomas
502-899-3366
StudyStartup@NCIResearch.org

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
LaToya Marshall
617-636-5409
latoya.marshall@tuftsmedicine.org

Hackensack Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Elizabeth McCarthy
412-860-6447
elizabethl.mccarthy@hmhn.org

Atlantic Health System
Morristown 5101427, New Jersey 5101760 07960
Contact:
Amanda Hall
973-971-5235
Amandamaria.hall@atlantichealth.org

Nyu Langone Health
New York 5128581, New York 5128638 10016
Contact:
MARK BOND
646-754-7217
Mark.Bond@nyulangone.org

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10461
Contact:
Joel Victor
718-430-8761
jovictor@montefiore.org

Oncology Hematology Care
Cincinnati 4508722, Ohio 5165418 45242
Contact:
Eric Clayton
513-751-2273
Eric.Clayton@usoncology.com

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Richard Maziarz, MD
503-494-6345
MAZIARZR@ohsu.edu

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Sunita Nasta
215-614-1846
Sunita.Nasta@pennmedicine.upenn.edu

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37323
Contact:
Dr. Olalekan Oluwole
615-936-8422
olalekan.oluwole@vanderbilt.edu

Baylor Charles A. Sammons Cancer Center
Dallas 4684888, Texas 4736286 75246
Contact:
Tarah Satterfield
214-818-8472
Tarah.Satterfield@BSWHealth.org

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4009
Contact:
Ly Dsouza
713-745-8614
ldsouza@mdanderson.org

Huntsman Cancer Institute at the University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Erin Peterson
801-587-4655
erin.peterson@hci.utah.edu

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
Contact:
Karen McClain
757-466-8683
Karen.mcclain@usoncology.com

Virginia Commonwealth University (VCU)
Richmond 4781708, Virginia 6254928 23219
Contact:
Kristin Lantis
804-628-2341
kllantis@vcu.edu

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Roisin McAndrew
414-805-5447
rmcandrew@mcw.edu

More Details

NCT ID
NCT04637763
Status
Recruiting
Sponsor
Caribou Biosciences, Inc.

Study Contact

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

Detailed Description

This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.