RECRUITING

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

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Conditions

Lymphoma, Non-HodgkinRelapsed Non Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaNon Hodgkin LymphomaLymphomaB Cell LymphomaB Cell Non-Hodgkin's Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2021-05-26
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04637763

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 at the time of enrollment
  2. * Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
  3. * Eastern Cooperative Oncology Group performance status 0 or 1
  4. * Adequate hematologic, renal, liver, cardiac and pulmonary organ function
  1. * Prior therapy with an anti-CD19 targeting agent
  2. * Active or chronic graft versus host disease requiring therapy
  3. * Prior allogeneic stem cell transplantation
  4. * Central nervous system (CNS) lymphoma, prior CNS malignancy
  5. * Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
  6. * Primary immunodeficiency
  7. * Current or expected need for systemic corticosteroid therapy
  8. * Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
  9. * Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
  10. * Unwillingness to follow extended safety monitoring

Contacts and Locations

Study Contact

Socorro Portella, MD
CONTACT
973 866 7567
clinicaltrials@cariboubio.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
HonorHealth
Scottsdale, Arizona, 85258
United States
University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of Arkansas
Little Rock, Arkansas, 72205
United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92073
United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90089
United States
Chao Family Comprehensive Cancer Center/University of California Irvine
Orange, California, 92868
United States
Advent Health
Orlando, Florida, 32803
United States
Bone and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, 52242
United States
University of Kentucky Markey Cancer
Lexington, Kentucky, 40536
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Hackensack Medical Center
Hackensack, New Jersey, 07601
United States
Atlantic Health System
Morristown, New Jersey, 07960
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Nyu Langone Health
New York, New York, 10016
United States
Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37323
United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23219
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Caribou Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • 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