CClinicalTrials.gg
Enrolling by invitationNCT05332054LTFSUpdated Mar 12, 2026

Long-Term Follow-up Study

An observational study in Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by Caribou Biosciences, Inc.. Enrolling by invitation at 31 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Caribou Biosciences, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • Allogeneic CAR-T
  • CB-010
  • CB-011
  • CB-012
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 159 observational studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Caribou Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BiologicalCaribou-sponsored investigational therapy

    N/A this is an observational study

06

What researchers measure

Primary outcomes

  1. Incidence of targeted NSAEs

    Incidence of targeted NSAEs

    Time frame: 15 Years

  2. Frequency of targeted NSAEs

    Frequency of targeted NSAEs

    Time frame: 15 Years

  3. Duration of targeted NSAEs

    Duration of targeted NSAEs

    Time frame: 15 Years

  4. Outcome of targeted NSAEs

    Outcome of targeted NSAEs

    Time frame: 15 Years

  5. Incidence of AESIs

    Incidence of AESIs

    Time frame: 15 Years

  6. Frequency of AESIs

    Frequency of AESIs

    Time frame: 15 Years

  7. Duration of AESIs

    Duration of AESIs

    Time frame: 15 Years

  8. Outcome of AESIs

    Outcome of AESIs

    Time frame: 15 Years

  9. Incidence of targeted SAEs

    Incidence of targeted SAEs

    Time frame: 15 Years

  10. Frequency of targeted SAEs

    Frequency of targeted SAEs

    Time frame: 15 Years

  11. Duration of targeted SAEs

    Duration of targeted SAEs

    Time frame: 15 Years

  12. Outcome of targeted SAEs

    Outcome of targeted SAEs

    Time frame: 15 Years

  13. Incidence of AEs related to IP leading to death

    Incidence of AEs related to IP leading to death

    Time frame: 15 Years

Secondary outcomes

  1. Overall survival

    Assessment of overall survival and disease progression as described in the SOA

    Time frame: 15 years

07

Study locations

31 sites
  • 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
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05332054
Lead sponsor
Caribou Biosciences, Inc.
Responsible party
Sponsor
First posted
Apr 18, 2022
Start date
Mar 16, 2022
Primary completion
Dec 2041 (estimated)
Completion
Dec 2041 (estimated)
Last update
Mar 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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