← Back to searchRecruitingRecruiting
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
NCT04637763 · Caribou Biosciences, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
About this study
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.
Eligibility criteria
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
Enrollment target: 72 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-26
Estimated completion: 2025-09
Last updated: 2025-03-24
Interventions
Genetic: CB-010Drug: CyclophosphamideDrug: Fludarabine
Primary outcomes
- • Primary outcome measures number of patients with dose-limiting toxicities (Part A). (28 days following CB-010 infusion)
- • Primary outcome evaluates tumor response (Part B) (Up to 12 months)
Sponsor
Caribou Biosciences, Inc. · industry
Contacts & investigators
ContactSocorro Portella, MD · contact · clinicaltrials@cariboubio.com · 973 866 7567
All locations (38)
University of Alabama at BirminghamTerminated
Birmingham, Alabama, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
HonorHealthRecruiting
Scottsdale, Arizona, United States
University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
University of ArkansasRecruiting
Little Rock, Arkansas, United States
University of California San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
University of Southern California, Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center/University of California IrvineRecruiting
Orange, California, United States
Advent HealthRecruiting
Orlando, Florida, United States
Bone and Marrow Transplant Group of GeorgiaRecruiting
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta UniversityRecruiting
Augusta, Georgia, United States
Holden Comprehensive Cancer Center at the University of IowaRecruiting
Iowa City, Iowa, United States
University of Kentucky Markey CancerRecruiting
Lexington, Kentucky, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Hackensack Medical CenterRecruiting
Hackensack, New Jersey, United States
Atlantic Health SystemRecruiting
Morristown, New Jersey, United States
Nyu Langone HealthRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Ohio State University James Cancer HospitalTerminated
Columbus, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Huntsman Cancer Institute at the University of UtahRecruiting
Salt Lake City, Utah, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Virginia Commonwealth University (VCU)Recruiting
Richmond, Virginia, United States
Swedish Cancer InstituteTerminated
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Epworth HealthcareRecruiting
Richmond, Victoria, Australia
Royal Perth HospitalRecruiting
Perth, Western Australia, Australia
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Tel Aviv Medical CenterRecruiting
Tel Aviv, Israel
The Sheba Fund for Health Services and Research (R.A.)Recruiting
Tel Litwinsky, Israel