CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
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
- Lymphoma, Non-Hodgkin
- Relapsed Non Hodgkin Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Non Hodgkin Lymphoma
- Lymphoma
- B Cell Lymphoma
- B Cell Non-Hodgkin's Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation of CB-010 |
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
|
|
Experimental Expansion of CB-010 |
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
|
Recruiting Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Gilbert, Arizona 85234
HonorHealth
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
University of Arizona Cancer Center
Tucson, Arizona 85724
Tucson, Arizona 85724
University of Arkansas
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California San Diego Moores Cancer Center
La Jolla, California 92073
La Jolla, California 92073
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California 90089
Los Angeles, California 90089
Chao Family Comprehensive Cancer Center/University of California Irvine
Orange, California 92868
Orange, California 92868
Advent Health
Orlando, Florida 32803
Orlando, Florida 32803
Bone and Marrow Transplant Group of Georgia
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Georgia Cancer Center at Augusta University
Augusta, Georgia 30912
Augusta, Georgia 30912
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kentucky Markey Cancer
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Norton Cancer Institute
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Hackensack Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Atlantic Health System
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Montefiore Medical Center
Bronx, New York 10461
Bronx, New York 10461
Nyu Langone Health
New York, New York 10016
New York, New York 10016
Oncology Hematology Care
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Vanderbilt University Medical Center
Nashville, Tennessee 37323
Nashville, Tennessee 37323
Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
Dallas, Texas 75246
MD Anderson Cancer Center
Houston, Texas 77030-4009
Houston, Texas 77030-4009
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Virginia Commonwealth University (VCU)
Richmond, Virginia 23219
Richmond, Virginia 23219
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT04637763
- Status
- Recruiting
- Sponsor
- Caribou Biosciences, Inc.
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.