CRISPR-edited CAR-T cell therapy for relapsed B cell lymphoma
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)
This study is testing a new CRISPR-edited CAR-T cell therapy to see if it can help adults with relapsed B cell lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Caribou Biosciences, Inc. Industry-sponsored |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 38 sites (Birmingham, Alabama and 37 other locations) |
| Trial ID | NCT04637763 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and emerging efficacy of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy, in adults with relapsed or refractory B cell non-Hodgkin lymphoma. The study is structured in two parts: Part A involves dose escalation using a 3 + 3 design to determine the optimal dose, while Part B focuses on expanding the patient cohort to receive the selected dose. Participants will undergo lymphodepletion with cyclophosphamide and fludarabine prior to receiving the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard treatments.
Not a fit: Patients with prior therapy using anti-CD19 targeting agents or those with active CNS lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients with difficult-to-treat relapsed or refractory B cell non-Hodgkin lymphoma.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 37 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Terminated)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- HonorHealth — Scottsdale, Arizona, United States (Recruiting)
- University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
- University of Arkansas — Little Rock, Arkansas, United States (Recruiting)
- University of California San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Chao Family Comprehensive Cancer Center/University of California Irvine — Orange, California, United States (Recruiting)
- Advent Health — Orlando, Florida, United States (Recruiting)
- Bone and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States (Recruiting)
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (Recruiting)
- Holden Comprehensive Cancer Center at the University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Kentucky Markey Cancer — Lexington, Kentucky, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Hackensack Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Atlantic Health System — Morristown, New Jersey, United States (Recruiting)
- Nyu Langone Health — New York, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Oncology Hematology Care — Cincinnati, Ohio, United States (Recruiting)
- Ohio State University James Cancer Hospital — Columbus, Ohio, United States (Terminated)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Virginia Oncology Associates — Norfolk, Virginia, United States (Recruiting)
- Virginia Commonwealth University (VCU) — Richmond, Virginia, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Terminated)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
- Epworth Healthcare — Richmond, Victoria, Australia (Recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
- The Sheba Fund for Health Services and Research (R.A.) — Tel Litwinsky, Israel (Recruiting)
Study contacts
- Study coordinator: Socorro Portella, MD
- Email: clinicaltrials@cariboubio.com
- Phone: 973 866 7567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.