Long-Term Follow-up Study

NCT ID: NCT05332054

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-16

Study Completion Date

2041-12-31

Brief Summary

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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

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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.

Conditions

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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 Hematologic Malignancy Relapsed/Refractory Multiple Myeloma Relapsed/Refractory Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed

consent for the LTFS

Caribou-sponsored investigational therapy

Intervention Type BIOLOGICAL

N/A this is an observational study

Interventions

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Caribou-sponsored investigational therapy

N/A this is an observational study

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caribou Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Honor Health Research Institute

Scottsdale, Arizona, United States

Site Status

University of California Irvine

Irvine, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, United States

Site Status

Blood & Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status

Augusta University/Georgia Cancer Center

Augusta, Georgia, United States

Site Status

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Regional Cancer Care Associates - Hackensack

Hackensack, New Jersey, United States

Site Status

Atlantic Health System Cancer Care

Morristown, New Jersey, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Levine Cancer Center

Charlotte, North Carolina, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute - TriStar Health

Nashville, Tennessee, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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LTFS

Identifier Type: -

Identifier Source: org_study_id

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