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Enrolling by invitationNCT06208878Updated Sep 24, 2026

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

An observational study in Hematologic Malignancy and Solid Malignancy, sponsored by CRISPR Therapeutics AG. Enrolling by invitation at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by CRISPR Therapeutics AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hematologic Malignancy
  • Solid Malignancy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • There are no specific exclusion criteria.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNon Interventional

    Safety and Efficacy Assessment

05

What researchers measure

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.

    Time frame: 15 years

Secondary outcomes

  1. 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.

    Time frame: 15 years

06

Study locations

24 sites
  • City of Hope
    Duarte, California 91010, United States
  • Cedars Sinai
    Los Angeles, California 90048, United States
  • Stanford
    Stanford, California 94305, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06510, United States
  • Emory
    Atlanta, Georgia 30322, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • University of Kansas
    Westwood, Kansas 66205, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Washington University Saint Louis
    St Louis, Missouri 63110, United States
  • MSKCC
    New York, New York 10065, United States
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • UT Southwestern
    Dallas, Texas 75390, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Methodist Hospital-Sarah Cannon
    San Antonio, Texas 78229, United States
  • University of Utah-Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
  • Peter MacCallum Cancer Center
    Melbourne, Victoria 3000, Australia
  • Alfred Health
    Melbourne, Australia
  • Sir Charles Gairdner
    Nedlands, 6009, Australia
  • Epworth Healthcare
    Richmond, Australia
  • Princess Margaret
    Toronto, Ontario M5G 2M9, Canada
  • University Hospital Hamburg-Eppendorf
    Hamburg, D-20246, Germany
07

Registry details

Key details

Study ID
NCT06208878
Lead sponsor
CRISPR Therapeutics AG
Responsible party
Sponsor
First posted
Jan 17, 2024
Start date
Nov 22, 2023
Primary completion
Aug 2038 (estimated)
Completion
Aug 2038 (estimated)
Last update
Sep 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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