Hematological MalignancyNCT05768269
A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product
An observational study of Hematological Malignancy and Solid Tumor Malignancy, run by Century Therapeutics, Inc. at 7 sites in United States.
Trial summary
This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Solid Tumor Malignancy
- How many people
- 375 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Apr 2024to Mar 2040
- 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: Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.
Who may be able to join
- Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.
- Participants received at least one treatment with a cellular therapy product in an eligible index trial.
- Participant was withdrawn, early discontinued or completed an eligible index trial.
- Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.
Who cannot join
- -This study has no exclusion criteria.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Dr Nancy Hardy, 410-328-1230, nhardy1@umm.edu
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Dr Moyo, 980-442-2301
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
Dr Latif, 513-584-7824
- Not yet recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Dr Matthew Ulrickson, 480-256-6444
- Not yet recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Dr Sami Brake, 616-486-5933, sami.brake@corewellhealth.org
- Not yet recruiting
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Dr Yaghmour, 323-865-3170
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
Dr. Krish Patel, 206-991-2040, krish.patel@swedish.org
About this study
Official title: A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.
- Conditions
- Hematological Malignancy, Solid Tumor Malignancy
- Being tested
- No Intervention
- Keywords
- Century Therapeutics, Cellular Therapy, Cell therapy, Malignancy
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cellular Therapy | Participants who have previously received an induced pluripotent stem cell (iPSC)-derived, ex vivo genome edited cellular therapy product in an eligible Century-sponsored index trial will be enrolled in this study for up to 180 months following the last treatment with a cellular therapy product in an eligible index trial. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With any Adverse Events of Special Interest (AESI)
Measured: Up to 180 months
Secondary outcomes (3)
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
Measured: Up to 180 months
Overall Survival (OS)
OS is defined as the time from first treatment with a cellular therapy product in the index trial to date of death by any cause.
Measured: From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)
Percentage of Participants With Persistent Product
Persistence of the cellular product will be assessed by a droplet digital polymerase chain reaction molecular test to evaluate transgene copies in the peripheral blood. Summary of persistence sample results (positive/negative) will be reported.
Measured: Up to 180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start29 Apr 2024
- Primary completionMar 2040 (estimated)
- Study completionMar 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological 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
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Century Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768269
- Sponsor's protocol ID
- CNTY-LTFU-01
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
- ClinicalTrials.gov ID
- NCT05768269
- Acronym / sponsor ID
- CNTY-LTFU-01
- Conditions
- Hematological Malignancy, Solid Tumor Malignancy
- Keywords
- Century Therapeutics, Cellular Therapy, Cell therapy, Malignancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Century Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Mar 2040 (estimated)
- Study completion
- Mar 2040 (estimated)
- First posted
- 14 Mar 2023 (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 is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cellular Therapy | – | Other: No InterventionParticipants who have previously received an induced pluripotent stem cell (iPSC)-derived, ex vivo genome edited cellular therapy product in an eligible Century-sponsored index trial will be enrolled in this study for up to 180 months following the last treatment with a cellular therapy product in an eligible index trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.
Key inclusion criteria (4 listed)
- Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.
- Participants received at least one treatment with a cellular therapy product in an eligible index trial.
- Participant was withdrawn, early discontinued or completed an eligible index trial.
- Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.
Key exclusion criteria (1 listed)
- -This study has no 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 |
|---|---|---|
| No InterventionAs this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered. | Other | Cellular Therapy |
Primary outcome
Number of Participants With any Adverse Events of Special Interest (AESI)
Time frame: Up to 180 months
3 secondary outcomes
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
Time frame: Up to 180 months
Overall Survival (OS)
Time frame: From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)
Percentage of Participants With Persistent Product
Time frame: Up to 180 months
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 25 Jun 2025.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancy and Solid Tumor Malignancy, run by Century Therapeutics, Inc. at 7 sites in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Contact Century Therapeutics Clinical Team (8885067670, trial_response_century@centurytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With any Adverse Events of Special Interest (AESI) (time frame: Up to 180 months). 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 25 Jun 2025.