Hematologic MalignancyNCT06208878
A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies
An observational study of Hematologic Malignancy and Solid Malignancy, run by CRISPR Therapeutics AG at 24 sites in 4 countries.
Trial summary
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Solid Malignancy
- What is being tested?
- Non Interventional
- How many people
- 70 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 22 Nov 2023to Aug 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
24 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 4 countries
United States17 sites
Emory
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60637
UT Southwestern
Dallas, Texas, 75390
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
Cedars Sinai
Los Angeles, California, 90048
University of Minnesota
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06510
MSKCC
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah-Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Methodist Hospital-Sarah Cannon
San Antonio, Texas, 78229
Washington University Saint Louis
St Louis, Missouri, 63110
Stanford
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
University of Kansas
Westwood, Kansas, 66205
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
Alfred Health
Melbourne
Sir Charles Gairdner
Nedlands, 6009
Epworth Healthcare
Richmond
About this study
Official title: 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
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.
- Conditions
- Hematologic Malignancy, Solid Malignancy
- Being tested
- Non Interventional
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionalOther
Safety and Efficacy Assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start22 Nov 2023
- Primary completionAug 2038 (estimated)
- Study completionAug 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CRISPR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208878
- Sponsor's protocol ID
- CRSP-ONC-LTF
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
- ClinicalTrials.gov ID
- NCT06208878
- Acronym / sponsor ID
- CRSP-ONC-LTF
- Conditions
- Hematologic Malignancy, Solid Malignancy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- CRISPR Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- Aug 2038 (estimated)
- Study completion
- Aug 2038 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Interventional | – | Other: Non 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non InterventionalSafety and Efficacy Assessment | Other | Non Interventional |
Primary outcome
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.
1 secondary outcome
The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy and Solid Malignancy, run by CRISPR Therapeutics AG at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.