Long-Term Follow-up Study

Lymphoma Clinical Trial

— LTFS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05332054
• Other study ID #: LTFS
• Status: Enrolling by invitation
• Start date: March 16, 2022
• Est. completion date: December 2041

Study information

• Verified date: May 2024
• Source: Caribou Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients who have participated in a prior Caribou-sponsored clinical study, in a special access program, or in another study such as an IIT. 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.

Description:

This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients who have participated in a prior Caribou-sponsored clinical study, in a special access program, or in another study such as an IIT. The purpose of this 15-year research study is to collect long-term observational data to identify and understand potential late side effects in these patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2041
• Est. primary completion date: December 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent obtained prior to study-specific activities/enrollment
• Received a Caribou 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 program or as part of an IIT

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• B Cell Lymphoma
• B-Cell Non-Hodgkin's Lymphoma
• Hematologic Malignancy
• Hematologic Neoplasms
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Relapsed Non-Hodgkin Lymphoma
• Relapsed/Refractory Acute Myeloid Leukemia
• Relapsed/Refractory Multiple Myeloma

Intervention

Biological:
• Allogeneic CAR-T therapy
N/A this is an observational study

Locations

Country	Name	City	State
United States	Blood & Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	Augusta University/Georgia Cancer Center	Augusta	Georgia
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of California Irvine	Irvine	California
United States	University of California San Diego	La Jolla	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Atlantic Health System Cancer Care	Morristown	New Jersey
United States	Sarah Cannon Research Institute - TriStar Health	Nashville	Tennessee
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	AdventHealth Medical Group Blood & Marrow Transplant at Orlando	Orlando	Florida
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah
United States	Honor Health Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Caribou Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of targeted AEs	Incidence of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Frequency of targeted AEs	Frequency of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Duration of targeted AEs	Duration of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Outcome of targeted AEs	Outcome of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Incidence of AESIs	Incidence of AESIs related to an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Frequency of AESIs	Frequency of AESIs related to an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Duration of AESIs	Duration of AESIs related to an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Outcome of AESIs	Outcome of AESIs related to an allogeneic CAR-T therapy infusion from enrollment into LTFS through Year 15	15 Years
Primary	Incidence of SUSARs	Incidence of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into LTFS through Year 15	15 Years
Primary	Frequency of SUSARs	Frequency of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into LTFS through Year 15	15 Years
Primary	Duration of SUSARs	Duration of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into LTFS through Year 15	15 Years
Primary	Outcome of SUSARs	Outcome of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into LTFS through Year 15	15 Years
Primary	Incidence of AEs related to an allogeneic CAR-T therapy leading to death	Incidence of AEs related to an allogeneic CAR-T therapy leading to death from enrollment into LTFS through Year 15	15 Years
Secondary	Overall survival	Assessment of overall survival at 3 months and 6 months post an allogeneic CAR-T therapy infusion, then yearly through Year 15	15 years