A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies

Hematologic Malignancy Clinical Trial

Official title:

A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06208878
• Other study ID #: CRSP-ONC-LTF
• Status: Enrolling by invitation
• Start date: November 22, 2023
• Est. completion date: August 2038

Study information

• Verified date: March 2024
• Source: CRISPR Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: August 2038
• Est. primary completion date: August 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Solid Malignancy

Intervention

Other:
• Non Interventional
Safety and Efficacy Assessment

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner	Nedlands
United States	Emory	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	City of Hope	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	Cedars Sinai	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	MSKCC	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University Saint Louis	Saint Louis	Missouri
United States	University of Utah-Huntsman Cancer Institute	Salt Lake City	Utah
United States	Methodist Hospital-Sarah Cannon	San Antonio	Texas
United States	Stanford	Stanford	California
United States	University of Kansas	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
CRISPR Therapeutics AG

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.	The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.	15 years
Secondary	The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment	Overall survival will be calculated as the time between the initial dose of CRISPR CAR T cellular therapy in the parent study and death due to any cause. Duration of remission/response will be calculated as the time between the first objective response to first disease progression or death due to any cause.	15 years