Advanced Solid TumorNCT04106167
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
An observational study of Advanced Solid Tumor and Lymphoma, run by Fate Therapeutics at 4 sites in United States.
Trial summary
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Lymphoma, Gastric Cancer
- What is being tested?
- Allogeneic natural killer (NK) cell
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jun 2019to 11 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Subjects with advance solid tumors rolling over from interventional study where they were treated with an allogeneic, iPSC-derived NK cell.
Who may be able to join
- Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
- Subjects who have provided Informed consent prior to their study participation
Who cannot join
- Not Applicable
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
UCSD Moores Cancer Center
San Diego, California, 92093
About this study
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.
The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
Read the detailed description
This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.
- Conditions
- Advanced Solid Tumor, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma
- Being tested
- Allogeneic natural killer (NK) cell
- Medical subject headings
- Lymphoma, Stomach Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Hepatocellular, Small Cell Lung Carcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic natural killer (NK) cellGenetic
No study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell in a previous trial will be evaluated in this trial for long-term safety and efficacy
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy | Long Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial. Receives: Genetic: Allogeneic natural killer (NK) cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) post-Infusion
OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause
Measured: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start11 Jun 2019
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Why it stopped: This study was terminated by the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fate Trial Disclosure, Study director, Fate Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106167
- Sponsor's protocol ID
- FT-003
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
- ClinicalTrials.gov ID
- NCT04106167
- Acronym / sponsor ID
- FT-003
- Conditions
- Advanced Solid Tumor, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated by the Sponsor.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 26 Sep 2019 (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.
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.
The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
Detailed description
This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy | – | Genetic: Allogeneic natural killer (NK) cellLong Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with advance solid tumors rolling over from interventional study where they were treated with an allogeneic, iPSC-derived NK cell.
Key inclusion criteria (2 listed)
- Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
- Subjects who have provided Informed consent prior to their study participation
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| Allogeneic natural killer (NK) cellNo study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell in a previous trial will be evaluated in this trial for long-term safety and efficacy | Genetic | Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy |
Primary outcome
Overall Survival (OS) post-Infusion
Time frame: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.
OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause
Results and safety
The study was stopped early (reason given: This study was terminated by the Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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. This study is not recruiting at the moment.
Fate Trial Disclosure study director
Fate Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumor and Lymphoma, run by Fate Therapeutics at 4 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 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: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was stopped early (reason given: This study was terminated by the Sponsor.). Results are not available in the source record.
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?
Overall Survival (OS) post-Infusion (time frame: From the date of study entry until the date of documented death due to any cause, assessed up to 60 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 21 Sep 2023.