CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
- Conditions
- Non Hodgkin LymphomaLymphoma, Non-HodgkinRelapsed Non Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaB Cell LymphomaB Cell Non-Hodgkin's LymphomaLymphoma
- Interventions
- Registration Number
- NCT04637763
- Lead Sponsor
- Caribou Biosciences, Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Expansion of CB-010 CB-010 Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Expansion of CB-010 Cyclophosphamide Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Dose Escalation of CB-010 CB-010 Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Dose Escalation of CB-010 Cyclophosphamide Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Expansion of CB-010 Fludarabine Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Dose Escalation of CB-010 Fludarabine Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
- Primary Outcome Measures
Name Time Method Primary outcome measures number of patients with dose-limiting toxicities (Part A). 28 days following CB-010 infusion Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Primary outcome evaluates tumor response (Part B) Up to 12 months The primary endpoint is objective response rate.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
University of Southern California, Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Chao Family Comprehensive Cancer Center/University of California Irvine
🇺🇸Orange, California, United States
Advent Health
🇺🇸Orlando, Florida, United States
Bone and Marrow Transplant Group of Georgia
🇺🇸Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Holden Comprehensive Cancer Center at the University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kentucky Markey Cancer
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Nyu Langone Health
🇺🇸New York, New York, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Ohio State University James Cancer Hospital
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University (VCU)
🇺🇸Richmond, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Epworth Healthcare
🇦🇺Richmond, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
The Sheba Fund for Health Services and Research (R.A.)
🇮🇱Tel HaShomer, Israel
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