Long-Term Follow-up Study
- Conditions
- LymphomaLymphoma, Non-HodgkinB Cell LymphomaRelapsed/Refractory Acute Myeloid LeukemiaRefractory B-Cell Non-Hodgkin LymphomaNon-Hodgkin LymphomaB-Cell Non-Hodgkin's LymphomaRelapsed Non-Hodgkin LymphomaHematologic MalignancyRelapsed/Refractory Multiple Myeloma
- Interventions
- Biological: Allogeneic CAR-T therapyBiological: Caribou-sponsored investigational therapy
- Registration Number
- NCT05332054
- Lead Sponsor
- Caribou Biosciences, Inc.
- Brief Summary
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
- Detailed Description
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 150
- Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment
- Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT
- Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who received a Caribou-sponsored allogeneic CAR-T therapy Allogeneic CAR-T therapy in a Caribou-sponsored clinical study, a special access program, or as part of an IIT Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed Caribou-sponsored investigational therapy consent for the LTFS
- Primary Outcome Measures
Name Time Method Incidence of targeted NSAEs 15 Years Incidence of targeted NSAEs
Frequency of targeted NSAEs 15 Years Frequency of targeted NSAEs
Duration of targeted NSAEs 15 Years Duration of targeted NSAEs
Outcome of targeted NSAEs 15 Years Outcome of targeted NSAEs
Incidence of AESIs 15 Years Incidence of AESIs
Frequency of AESIs 15 Years Frequency of AESIs
Duration of AESIs 15 Years Duration of AESIs
Outcome of AESIs 15 Years Outcome of AESIs
Incidence of targeted SAEs 15 Years Incidence of targeted SAEs
Frequency of targeted SAEs 15 Years Frequency of targeted SAEs
Duration of targeted SAEs 15 Years Duration of targeted SAEs
Outcome of targeted SAEs 15 Years Outcome of targeted SAEs
Incidence of AEs related to IP leading to death 15 Years Incidence of AEs related to IP leading to death
- Secondary Outcome Measures
Name Time Method Overall survival 15 years Assessment of overall survival and disease progression as described in the SOA
Trial Locations
- Locations (28)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Regional Cancer Care Associates - Hackensack
🇺🇸Hackensack, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
University of California Irvine
🇺🇸Irvine, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
🇺🇸Orlando, Florida, United States
Blood & Marrow Transplant Group of Georgia
🇺🇸Atlanta, Georgia, United States
Augusta University/Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Atlantic Health System Cancer Care
🇺🇸Morristown, New Jersey, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon Research Institute - TriStar Health
🇺🇸Nashville, Tennessee, United States
Baylor Research Institute
🇺🇸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