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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Hematologic Malignancy; Solid Malignancy
• Intervention / Treatment: Other: Non Interventional

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Saint Louis
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital-Sarah Cannon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Safety and Efficacy Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CRISPR Therapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): August 1, 2038

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: CRSP-ONC-LTF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No