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CB-Long-Term Safety Study (CB-LTSS) (CB-LTSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05332054
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Caribou Biosciences, Inc.

Study Description
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Brief Summary:
This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients with hematologic malignancies. Its purpose of is to collect long-term observational data to identify and understand potential late side effects in patients who have received CAR-T cell therapies.

Condition or disease Intervention/treatment
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 Biological: Allogeneic CAR-T therapy

Detailed Description:
This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients with hematologic malignancies. The purpose of this 15-year research study is to collect long-term observational data to identify and understand potential late side effects in patients who have received CAR-T cell therapies as part of a previous Caribou-sponsored study or a Caribou-sponsored special access program.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Evaluate Long-Term Safety of CAR-T Cell Therapy in Patients With Hematologic Malignancies
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : December 2041
Estimated Study Completion Date : December 2041

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients who received a Caribou-sponsored allogeneic CAR-T therapy
in a Caribou-sponsored clinical study or special access program
 Biological: Allogeneic CAR-T therapy
N/A this is an observational study


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of targeted AEs [ Time Frame: 15 Years ]
    Incidence of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  2. Frequency of targeted AEs [ Time Frame: 15 Years ]
    Frequency of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  3. Duration of targeted AEs [ Time Frame: 15 Years ]
    Duration of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  4. Outcome of targeted AEs [ Time Frame: 15 Years ]
    Outcome of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  5. Incidence of serious AESIs [ Time Frame: 15 Years ]
    Incidence of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  6. Frequency of serious AESIs [ Time Frame: 15 Years ]
    Frequency of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  7. Duration of serious AESIs [ Time Frame: 15 Years ]
    Duration of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  8. Outcome of serious AESIs [ Time Frame: 15 Years ]
    Outcome of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15

  9. Incidence of SUSARs [ Time Frame: 15 Years ]
    Incidence of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15

  10. Frequency of SUSARs [ Time Frame: 15 Years ]
    Frequency of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15

  11. Duration of SUSARs [ Time Frame: 15 Years ]
    Duration of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15

  12. Outcome of SUSARs [ Time Frame: 15 Years ]
    Outcome of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15

  13. Incidence of AEs related to an allogeneic CAR-T therapy leading to death [ Time Frame: 15 Years ]
    Incidence of AEs related to an allogeneic CAR-T therapy leading to death from enrollment into CB-LTSS through Year 15


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 15 years ]
    Assessment of overall survival at 3 months and 6 months post an allogeneic CAR-T therapy infusion, then yearly through Year 15


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received an allogeneic CAR-T therapy in a Caribou-sponsored clinical study or special access program and provided informed consent for the CB-LTSS
Criteria

Inclusion Criteria:

  • Written informed consent obtained prior to study-specific activities/enrollment
  • Received an allogeneic CAR-T therapy and completed or discontinued from a Caribou-sponsored study evaluating an allogeneic CAR-T therapy or was administered an allogeneic CAR-T therapy under a special access mechanism

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05332054


Locations
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United States, California
University of California Irvine
Irvine, California, United States, 92868
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Caribou Biosciences, Inc.
More Information
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Responsible Party: Caribou Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05332054    
Other Study ID Numbers: CB-LTSS
First Posted: April 18, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caribou Biosciences, Inc.:
Allogeneic CAR-T
CB-010
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases