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

NCT06208878 | Enrolling By Invitation

• 1 other identifier: CRSP-ONC-LTF
• Study Type: observational
• Target: 70
• Locations: 4 countries
• Sites: 22

Brief Summary

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

Conditions

Hematologic Malignancy; Solid Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment

  15 years

Study Arms (1)

Non Interventional

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.

Other: Non Interventional

Interventions

Non Interventional OTHER

Safety and Efficacy Assessment

Non Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• CRISPR Therapeutics AG: lead

Study Sites (22)

City of Hope

Duarte, California, 91010, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas

Westwood, Kansas, 66205, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University Saint Louis

St Louis, Missouri, 63110, United States

Location

MSKCC

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Methodist Hospital-Sarah Cannon

San Antonio, Texas, 78229, United States

Location

University of Utah-Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

Location

Sir Charles Gairdner

Nedlands, 6009, Australia

Location

Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

Location

University Hospital Hamburg-Eppendorf

Hamburg, D-20246, Germany

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 17, 2024
• Study Start: November 22, 2023
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): August 1, 2038
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

DE (1); US (17); AU (3); CA (1)