Solid Tumor, AdultPhase 1NCT04551885
FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
A Phase 1 study testing FT516, Avelumab and Cyclophosphamide in people with Solid Tumor, Adult, run by Fate Therapeutics at 3 sites in United States.
Trial summary
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- FT516, Avelumab and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Sep 2020to 11 Aug 2023
- Phase
- Phase 1
- 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
Who may be able to join
- Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab
- Capable of giving signed informed consent
- Aged ≥ 18 years old
- Willingness to comply with study procedures and duration
- Measurable disease per iRECIST
- Contraceptive use for women and men as defined in the protocol
Who cannot join
- Pregnant or breast-feeding women
- ECOG performance status ≥ 2
- Evidence of insufficient organ function
- Clinically significant cardiovascular disease
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
- Known active central nervous system (CNS) involvement by malignancy
Show all 11Show fewer
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
- Currently receiving or likely to require immunosuppressive therapy
- Known active infections with Hepatitis B, Hepatitis C or HIV
- Live vaccine within 6 weeks prior to start of lympho-conditioning
- Known allergy to albumin (human) or DMSO
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack University Medical Center/John Theurer Cancer Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
- Conditions
- Solid Tumor, Adult
- Being tested
- FT516, Avelumab, Cyclophosphamide, Fludarabine, IL-2
- Keywords
- PD-L1, cellular therapy, NK cells, urothelial cancer, renal cell carcinoma, merkel cell carcinoma, non-small cell lung cancer, NSCLC, triple negative breast cancer, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Merkel Cell, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT516Drug
Experimental Interventional Therapy
AvelumabDrug
Also called Bavencio
Monoclonal antibody
CyclophosphamideDrug
Lympho-conditioning agent
FludarabineDrug
Lympho-conditioning agent
IL-2Drug
Also called Proleukin, Aldesleukin
Biologic response modifier
| Study group | Role | What they receive |
|---|---|---|
| FT516 in combination with avelumab | Experimental | Not described Receives: Drug: FT516; Drug: Avelumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
Measured: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
Severity of DLTs Within Each Dose Level Cohort
The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (6)
Number of Participants with ≥1 Adverse Events (AE)
An AE is any untoward medical occurrence in a participants temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to 15 years
Investigator-Assessed Duration of Response (DOR)
DOR is the time from the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per modified Response Evaluation Criteria in Solid Tumors (iRECIST) response criteria.
Measured: Up to 15 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria.
Measured: Up to 15 years
Progression Free Survival (PFS)
PFS is defined as the time from first dose of lympho-conditioning to disease progression or to the day of death for any reason, whichever occurs first, per iRECIST response criteria.
Measured: Up to 15 years
Overall Survival (OS)
OS is defined as the time from first dose of lympho-conditioning to death from any cause.
Measured: Up to 15 years
Determination of PK of FT516 in peripheral blood
The pharmacokinetics of FT516 in peripheral blood will be reported as the relative percentage of product (FT516) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Measured: Study Days 1, 2, 4, 8, 11, 18, 22, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start7 Sep 2020
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04551885
- Sponsor's protocol ID
- FT516-102
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu H, Blum RH, Bjordahl R, Gaidarova S, Rogers P, Lee TT, Abujarour R, Bonello GB, Wu J, Tsai PF, Miller JS, Walcheck B, Valamehr B, Kaufman DS. Pluripotent stem cell-derived NK cells with high-affinity noncleavable CD16a mediate improved antitumor activity. Blood. 2020 Feb 6;135(6):399-410. doi: 10.1182/blood.2019000621.
PubMed 31856277
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
- A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04551885
- Acronym / sponsor ID
- FT516-102
- Conditions
- Solid Tumor, Adult
- Keywords
- PD-L1, cellular therapy, NK cells, urothelial cancer, renal cell carcinoma, merkel cell carcinoma, non-small cell lung cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated by the Sponsor.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 16 Sep 2020 (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 is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FT516 in combination with avelumab | Experimental | Drug: FT516, Drug: Avelumab, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: IL-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab
- Capable of giving signed informed consent
- Aged ≥ 18 years old
- Willingness to comply with study procedures and duration
- Measurable disease per iRECIST
Key exclusion criteria (11 listed)
- Pregnant or breast-feeding women
- ECOG performance status ≥ 2
- Evidence of insufficient organ function
- Clinically significant cardiovascular disease
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
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 |
|---|---|---|
| FT516Experimental Interventional Therapy | Drug | FT516 in combination with avelumab |
| AvelumabAlso: BavencioMonoclonal antibody | Drug | FT516 in combination with avelumab |
| CyclophosphamideLympho-conditioning agent | Drug | FT516 in combination with avelumab |
| FludarabineLympho-conditioning agent | Drug | FT516 in combination with avelumab |
| IL-2Also: Proleukin, AldesleukinBiologic response modifier | Drug | FT516 in combination with avelumab |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
Time frame: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
Severity of DLTs Within Each Dose Level Cohort
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
6 secondary outcomes
Number of Participants with ≥1 Adverse Events (AE)
Time frame: Up to 15 years
Investigator-Assessed Duration of Response (DOR)
Time frame: Up to 15 years
Disease Control Rate (DCR)
Time frame: Up to 15 years
Progression Free Survival (PFS)
Time frame: Up to 15 years
Overall Survival (OS)
Time frame: Up to 15 years
Determination of PK of FT516 in peripheral blood
Time frame: Study Days 1, 2, 4, 8, 11, 18, 22, 29
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.
- Background: PubMed 31856277Zhu H, Blum RH, Bjordahl R, Gaidarova S, Rogers P, Lee TT, Abujarour R, Bonello GB, Wu J, Tsai PF, Miller JS, Walcheck B, Valamehr B, Kaufman DS. Pluripotent stem cell-derived NK cells with high-affinity noncleavable CD16a mediate improved antitumor activity. Blood. 2020 Feb 6;135(6):399-410. doi: 10.1182/blood.2019000621.
- 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. This study is not recruiting at the moment.
Fate Trial Disclosure study director
Fate Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT516, Avelumab and Cyclophosphamide in people with Solid Tumor, Adult, run by Fate Therapeutics at 3 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 6 inclusion and 11 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 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort (time frame: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551885, which also lists 1 linked publication.
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.