Long-Term Follow-up Study
LTFS
An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
1 other identifier
observational
150
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2041
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2041
March 12, 2026
March 1, 2026
19.7 years
March 21, 2022
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Incidence of targeted NSAEs
Incidence of targeted NSAEs
15 Years
Frequency of targeted NSAEs
Frequency of targeted NSAEs
15 Years
Duration of targeted NSAEs
Duration of targeted NSAEs
15 Years
Outcome of targeted NSAEs
Outcome of targeted NSAEs
15 Years
Incidence of AESIs
Incidence of AESIs
15 Years
Frequency of AESIs
Frequency of AESIs
15 Years
Duration of AESIs
Duration of AESIs
15 Years
Outcome of AESIs
Outcome of AESIs
15 Years
Incidence of targeted SAEs
Incidence of targeted SAEs
15 Years
Frequency of targeted SAEs
Frequency of targeted SAEs
15 Years
Duration of targeted SAEs
Duration of targeted SAEs
15 Years
Outcome of targeted SAEs
Outcome of targeted SAEs
15 Years
Incidence of AEs related to IP leading to death
Incidence of AEs related to IP leading to death
15 Years
Secondary Outcomes (1)
Overall survival
15 years
Study Arms (1)
Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed
consent for the LTFS
Interventions
N/A this is an observational study
Eligibility Criteria
Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of Alabama
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
University of California Irvine
Irvine, California, 92868, United States
University of California San Diego
La Jolla, California, 92093, United States
University of Colorado
Denver, Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Miami
Miami, Florida, 33136, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, 32804, United States
Blood & Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Augusta University/Georgia Cancer Center
Augusta, Georgia, 30912, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Regional Cancer Care Associates - Hackensack
Hackensack, New Jersey, 07601, United States
Atlantic Health System Cancer Care
Morristown, New Jersey, 07960, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Levine Cancer Center
Charlotte, North Carolina, 28204, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute - TriStar Health
Nashville, Tennessee, 37203, United States
University of Texas Southwestern
Dallas, Texas, 75235, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 18, 2022
Study Start
March 16, 2022
Primary Completion (Estimated)
December 1, 2041
Study Completion (Estimated)
December 1, 2041
Last Updated
March 12, 2026
Record last verified: 2026-03