Clinical trial NCT05332054: Long-Term Follow-up Study
Official title: An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: 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
Lead sponsor: Caribou Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of targeted NSAEs
timeFrame: 15 Years
measure: Frequency of targeted NSAEs
timeFrame: 15 Years
measure: Duration of targeted NSAEs
timeFrame: 15 Years
measure: Outcome of targeted NSAEs
timeFrame: 15 Years
measure: Incidence of AESIs
timeFrame: 15 Years
measure: Frequency of AESIs
timeFrame: 15 Years
measure: Duration of AESIs
timeFrame: 15 Years
measure: Outcome of AESIs
timeFrame: 15 Years
measure: Incidence of targeted SAEs
timeFrame: 15 Years
measure: Frequency of targeted SAEs
timeFrame: 15 Years
measure: Duration of targeted SAEs
timeFrame: 15 Years
measure: Outcome of targeted SAEs
timeFrame: 15 Years
measure: Incidence of AEs related to IP leading to death
timeFrame: 15 Years
Secondary outcomes:
measure: Overall survival
timeFrame: 15 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando
state: Florida
city: Atlanta
country: United States
facility: Blood & Marrow Transplant Group of Georgia
state: Georgia
city: Augusta
country: United States
facility: Augusta University/Georgia Cancer Center
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Hackensack
country: United States
facility: Regional Cancer Care Associates - Hackensack
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System Cancer Care
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - TriStar Health
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: