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Enrolling by Invitation

NCT Number: NCT05332054

Long-Term Follow-up Study

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin B Cell Lymphoma B-cell Non-Hodgkin's Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Non-Hodgkin Lymphoma Paraproteinemias Refractory B-Cell Non-Hodgkin Lymphoma Relapsed Non-Hodgkin Lymphoma Relapsed/Refractory Acute Myeloid Leukemia Relapsed/Refractory Multiple Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caribou-sponsored investigational therapy

Biological

N/A this is an observational study

Primary outcomes

  1. Incidence of targeted NSAEs

    Time frame: 15 Years

    Incidence of targeted NSAEs

  2. Frequency of targeted NSAEs

    Time frame: 15 Years

    Frequency of targeted NSAEs

  3. Duration of targeted NSAEs

    Time frame: 15 Years

    Duration of targeted NSAEs

  4. Outcome of targeted NSAEs

    Time frame: 15 Years

    Outcome of targeted NSAEs

  5. Incidence of AESIs

    Time frame: 15 Years

    Incidence of AESIs

  6. Frequency of AESIs

    Time frame: 15 Years

    Frequency of AESIs

  7. Duration of AESIs

    Time frame: 15 Years

    Duration of AESIs

  8. Outcome of AESIs

    Time frame: 15 Years

    Outcome of AESIs

  9. Incidence of targeted SAEs

    Time frame: 15 Years

    Incidence of targeted SAEs

  10. Frequency of targeted SAEs

    Time frame: 15 Years

    Frequency of targeted SAEs

  11. Duration of targeted SAEs

    Time frame: 15 Years

    Duration of targeted SAEs

  12. Outcome of targeted SAEs

    Time frame: 15 Years

    Outcome of targeted SAEs

  13. Incidence of AEs related to IP leading to death

    Time frame: 15 Years

    Incidence of AEs related to IP leading to death

Secondary outcomes

  1. Overall survival

    Time frame: 15 years

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

Sponsors and collaborators

Lead sponsor

Caribou Biosciences, Inc.

Industry

Registry information

Official study title

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

Acronym: LTFS

Important dates

Study start
2022
Primary completion
2041
Study completion
2041
First posted
Apr 18, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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