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

Conditions
Solid Malignancy
Hematologic Malignancy
Interventions
Other: Non Interventional
Registration Number
NCT06208878
Lead Sponsor
CRISPR Therapeutics AG
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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
70
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.
Read More
Exclusion Criteria
  • There are no specific exclusion criteria.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non InterventionalNon InterventionalAll 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.
Primary Outcome Measures
NameTimeMethod
The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.15 years

The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.

Secondary Outcome Measures
NameTimeMethod
The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment15 years

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.

Trial Locations

Locations (21)

Stanford

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Stanford, California, United States

UT Southwestern

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Dallas, Texas, United States

Peter MacCallum Cancer Center

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Melbourne, Victoria, Australia

Yale New Haven Hospital

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New Haven, Connecticut, United States

University of Minnesota

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Minneapolis, Minnesota, United States

Oregon Health and Science University

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Portland, Oregon, United States

University of Utah-Huntsman Cancer Institute

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Salt Lake City, Utah, United States

City of Hope

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Duarte, California, United States

Cedars Sinai

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Los Angeles, California, United States

Emory

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Atlanta, Georgia, United States

University of Kansas

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Westwood, Kansas, United States

Washington University Saint Louis

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Saint Louis, Missouri, United States

MSKCC

πŸ‡ΊπŸ‡Έ

New York, New York, United States

University of Pennsylvania

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Methodist Hospital-Sarah Cannon

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San Antonio, Texas, United States

Royal Prince Alfred Hospital

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Camperdown, New South Wales, Australia

University Hospital Hamburg-Eppendorf

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Hamburg, Germany

Sir Charles Gairdner

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Nedlands, Australia

Princess Margaret

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Toronto, Ontario, Canada

Montefiore Medical Center

πŸ‡ΊπŸ‡Έ

Bronx, New York, United States

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