Clinical trial NCT06208878: A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies
Official title: A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hematologic Malignancy
Solid Malignancy
Lead sponsor: CRISPR Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 70
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: All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.

Brief summary: This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies

Detailed description: All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.

Eligibility criteria: Inclusion Criteria:

* Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document.
* Must have received CRISPR CAR T cellular therapy.

Exclusion Criteria:

* There are no specific exclusion criteria.

Primary outcomes:
measure: The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
timeFrame: 15 years
Secondary outcomes:
measure: The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment
timeFrame: 15 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Westwood
country: United States
facility: University of Kansas
state: Kansas
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Saint Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: MSKCC
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital-Sarah Cannon
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah-Huntsman Cancer Institute
state: Utah
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner
city: Toronto
country: Canada
facility: Princess Margaret
state: Ontario
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
References: