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

Sponsor

Caribou Biosciences, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05332054

Collaborator

(none)

100

Enrollment

Locations

236.6

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Mar 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2041

Anticipated Study Completion Date :

Dec 1, 2041

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Incidence of targeted AEs [15 Years]
Incidence of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Frequency of targeted AEs [15 Years]
Frequency of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Duration of targeted AEs [15 Years]
Duration of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Outcome of targeted AEs [15 Years]
Outcome of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Incidence of serious AESIs [15 Years]
Incidence of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Frequency of serious AESIs [15 Years]
Frequency of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Duration of serious AESIs [15 Years]
Duration of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Outcome of serious AESIs [15 Years]
Outcome of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15
Incidence of SUSARs [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
Frequency of SUSARs [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
Duration of SUSARs [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
Outcome of SUSARs [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
Incidence of AEs related to an allogeneic CAR-T therapy leading to death [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

Overall survival [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine	Irvine	California	United States	92868
2	Oncology Hematology Care	Cincinnati	Ohio	United States	45242
3	Baylor Research Institute	Dallas	Texas	United States	75246
4	MD Anderson Cancer Center	Houston	Texas	United States	77030