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Enrolling by Invitation

NCT Number: NCT06208878

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

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

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Solid Malignancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non Interventional

Other

Safety and Efficacy Assessment

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.

    Time frame: 15 years

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

Secondary outcomes

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

    Time frame: 15 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.

Sponsors and collaborators

Lead sponsor

CRISPR Therapeutics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2038
Study completion
2038
First posted
Jan 17, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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