Long-Term Follow-up Study (LTFS)

March 11, 2026 updated by: Caribou Biosciences, Inc.

An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • California
      • Irvine, California, United States, 92868
        • University of California Irvine
      • La Jolla, California, United States, 92093
        • University of California San Diego
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32804
        • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Blood & Marrow Transplant Group of Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University/Georgia Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Regional Cancer Care Associates - Hackensack
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System Cancer Care
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - TriStar Health
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at the University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed
consent for the LTFS
Biological: Caribou-sponsored investigational therapy
N/A this is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of targeted NSAEs
Time Frame: 15 Years
Incidence of targeted NSAEs
15 Years
Frequency of targeted NSAEs
Time Frame: 15 Years
Frequency of targeted NSAEs
15 Years
Duration of targeted NSAEs
Time Frame: 15 Years
Duration of targeted NSAEs
15 Years
Outcome of targeted NSAEs
Time Frame: 15 Years
Outcome of targeted NSAEs
15 Years
Incidence of AESIs
Time Frame: 15 Years
Incidence of AESIs
15 Years
Frequency of AESIs
Time Frame: 15 Years
Frequency of AESIs
15 Years
Duration of AESIs
Time Frame: 15 Years
Duration of AESIs
15 Years
Outcome of AESIs
Time Frame: 15 Years
Outcome of AESIs
15 Years
Incidence of targeted SAEs
Time Frame: 15 Years
Incidence of targeted SAEs
15 Years
Frequency of targeted SAEs
Time Frame: 15 Years
Frequency of targeted SAEs
15 Years
Duration of targeted SAEs
Time Frame: 15 Years
Duration of targeted SAEs
15 Years
Outcome of targeted SAEs
Time Frame: 15 Years
Outcome of targeted SAEs
15 Years
Incidence of AEs related to IP leading to death
Time Frame: 15 Years
Incidence of AEs related to IP leading to death
15 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 15 years
Assessment of overall survival and disease progression as described in the SOA
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Estimated)

December 1, 2041

Study Completion (Estimated)

December 1, 2041

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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