Lymphoma Clinical Trial
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)
NCT number | NCT04637763 |
Other study ID # | CB10A |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 26, 2021 |
Est. completion date | September 2025 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | September 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Epworth Healthcare | Richmond | Victoria |
Australia | Westmead Hospital | Westmead | New South Wales |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petah Tikva | |
Israel | Tel Aviv Medical Center | Tel Aviv | |
United States | Bone and Marrow Transplant Group of Georgia | Atlanta | Georgia |
United States | Georgia Cancer Center at Augusta University | Augusta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | Oncology Hematology Care | Cincinnati | Ohio |
United States | Ohio State University James Cancer Hospital | Columbus | Ohio |
United States | Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | Hackensack Medical Center | Hackensack | New Jersey |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Holden Comprehensive Cancer Center at the University of Iowa | Iowa City | Iowa |
United States | University of California San Diego Moores Cancer Center | La Jolla | California |
United States | University of Kentucky Markey Cancer | Lexington | Kentucky |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Atlantic Health System | Morristown | New Jersey |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Nyu Langone Health | New York | New York |
United States | Chao Family Comprehensive Cancer Center/University of California Irvine | Orange | California |
United States | Advent Health | Orlando | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah |
United States | HonorHealth | Scottsdale | Arizona |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | University of Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Caribou Biosciences, Inc. |
United States, Australia, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome measures number of patients with dose-limiting toxicities (Part A). | Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion. | 28 days following CB-010 infusion | |
Primary | Primary outcome evaluates tumor response (Part B) | The primary endpoint is objective response rate. | Up to 12 months |
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