Advanced Solid TumorsPhase 1NCT03841110
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
A Phase 1 study testing FT500, Nivolumab and Pembrolizumab in people with Advanced Solid Tumors and Lymphoma, run by Fate Therapeutics at 4 sites in United States.
Trial summary
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma, Gastric Cancer
- What is being tested?
- FT500, Nivolumab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Feb 2019to 15 Nov 2022
- 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
- 1. Diagnosis of the following, as per Regimen Cohort:
- 1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a participant who has failed or refused available FDA-approved therapies and is now a candidate for salvage therapy.
- 1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced solid tumor malignancy, including lymphomas, that has progressed on treatment with at least one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a participant who has also failed or refused other available approved therapies and is now a candidate for salvage therapy.
- 1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid tumor malignancy or lymphoma in a participant with disease relapse or progression on an ICI (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective USPI.
- 2. Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 3. Age >18 years old at the time of signing the ICF. 4. Presence of measurable disease by iRECIST or RECIL criteria, assessed before the start of lympho-conditioning and within 28 days prior to Day 1.
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- 5. Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 5a. Female participants: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of CY, at least 4 months after the final dose of FT500, at least 4 months after the final dose of pembrolizumab, and at least 5 months after the final dose of nivolumab or atezolizumab, whichever is latest.
- 5b. Male participants: Males must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 14 months after the final dose of CY, at least 6 months after the final dose of FT500, at least 6 months after the final dose of pembrolizumab, and at least 7 months after the final dose of nivolumab or atezolizumab, whichever is latest.
- 6. Willingness to comply with study procedures through the planned study duration. For patients with >1 measurable lesion, agreement to undergo a biopsy from a safely accessible site per Investigator assessment for exploratory biomarker assessments.
- 7. Provision of signed and dated ICF to agree to participate, at time of withdrawal or completion of this study, in Fate Therapeutics' long-term, non-interventional, observational study, FT-003.
Who cannot join
- All participants:
- 1. Females who are pregnant or breastfeeding. 2. ECOG performance status ≥ 2. 3. Evidence of insufficient organ function as determined by any one of the following: 3a. Neutrophils <1000/µL or platelets <75,000/µL. 3b. Estimated creatinine clearance <50 mL/minute (Cockcroft-gault). 3c. Total bilirubin >2 x upper limit normal (ULN) with the exception of participants with Gilbert's Syndrome or known liver metastases.
- 3d. Aspartate aminotransferase (AST) >3 x ULN, or alanine aminotransferase (ALT) >3 x ULN. For participants with known liver metastases, AST or ALT >5 x ULN.
- 3e. Oxygen saturation <90% on room air. 3f. Left ventricular ejection fraction (LVEF) <40% (eg by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan).
- 4.Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation) within 2 weeks prior to Day 1. Participants in Regimen B currently taking an ICI must interrupt ICI dosing at least 2 weeks prior to Day 1.
- 5. CNS metastases that have not been treated; or treated CNS metastases that have not been stable for at least 4 weeks.
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- 6. Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association grade 2 or higher.
- 7. Currently receiving or likely to require systemic immunosuppressive therapy (eg, prednisone >5 mg daily) for any reason from Day -7 to Day 29.
- 8. Uncontrolled infections. 9. Known allergy to the following FT500 components: Albumin (Human) or DMSO. 10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to participant.
- 11. Any medical condition or clinical laboratory abnormality that, per Investigator or Medical Monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results. Participants who have had prior receipt of a Fate Therapeutics investigational human iPSC product may be eligible for the study with approval from the Medical Monitor.
- Additional Exclusion Criteria for Regimen B: FT500 + ICI:
- 11. Participants who experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
- 12. Presence or history of autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, Crohn's disease, ulcerative colitis), except for participants with isolated vitiligo, atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and controlled thyroid disease.
- 13. Participants who have received an allograft organ transplant.
Trial locations and contacts
4 sites in 1 country.
United States4 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
UCSD Moores Cancer Center
San Diego, California, 92093
About this study
Official title: FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1)
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma
- Being tested
- FT500, Nivolumab, Pembrolizumab, Atezolizumab, Cyclophosphamide
- Keywords
- Advanced Solid Tumor, Lymphoma, Breast Cancer, Head and Neck Cancer, Head and Neck, Squamous Cell Carcinoma, Gastric Cancer, Colorectal Cancer, Immunotherapy, NK cell therapy, Melanoma, Checkpoint Inhibitor, Immune Checkpoint Inhibitor, Monoclonal Antibody, Cell therapy, Cellular therapy, nivolumab, pembrolizumab, atezolizumab
- 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.
FT500Drug
FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
NivolumabDrug
Also called OPDIVO
Immune Checkpoint Inhibitor
PembrolizumabDrug
Also called KEYTRUDA
Immune Checkpoint Inhibitor
AtezolizumabDrug
Also called TECENTRIQ
Immune Checkpoint Inhibitor
CyclophosphamideDrug
Lympho-conditioning agent
FludarabineDrug
Lympho-conditioning agent
IL-2Drug
Also called Proleukin, Aldesleukin
Biologic response modifier
| Study group | Role | What they receive |
|---|---|---|
| FT500 Monotherapy | Experimental | FT500 administered once weekly for 3 weeks as a monotherapy Receives: Drug: FT500; Drug: Cyclophosphamide; Drug: Fludarabine |
| FT500 in Combination with Immune Checkpoint Inhibitor | Experimental | FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab. Receives: Drug: FT500; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cyclophosphamide; Drug: Fludarabine |
| FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor | Experimental | FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab. Receives: Drug: FT500; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of participants with Dose Limiting Toxicities (DLTs) within each dose level cohort.
The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).
Measured: Day 29
Secondary outcomes (2)
Objective-response rate (ORR)
ORR is defined as the proportion of participants who achieve immune partial reponse/partial response (iPR/PR) or immune complete response/complete response (iCR/CR). Tumor response will be assessed using modified Response Evaluation Criteria in Solid Tumors (iRECIST) or Response Evaluation Criteria in Lymphoma (RECIL), as applicable.
Measured: Day 29 and every 8 weeks thereafter through Day 366
Duration of FT500 persistence
Duration of FT500 response is defined as duration from Day 1 to undetectable levels of FT500 cells per uL blood.
Measured: Day 1 through Day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Feb 2019
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fate Trial Disclosure, Study director, FateTrialDisclosure@fatetherapeutics.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841110
- Sponsor's protocol ID
- FT500-101
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1)
- ClinicalTrials.gov ID
- NCT03841110
- Acronym / sponsor ID
- FT500-101
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma
- Keywords
- Advanced Solid Tumor, Lymphoma, Breast Cancer, Head and Neck Cancer, Head and Neck, Squamous Cell Carcinoma, Gastric Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Feb 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.
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FT500 Monotherapy | Experimental | Drug: FT500, Drug: Cyclophosphamide, Drug: FludarabineFT500 administered once weekly for 3 weeks as a monotherapy |
| FT500 in Combination with Immune Checkpoint Inhibitor | Experimental | Drug: FT500, Drug: Nivolumab, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cyclophosphamide, Drug: FludarabineFT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab. |
| FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor | Experimental | Drug: FT500, Drug: Nivolumab, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: IL-2FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a participant who has failed or refused available FDA-approved therapies and is now a candidate for salvage therapy.
- 1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced solid tumor malignancy, including lymphomas, that has progressed on treatment with at least one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a participant who has also failed or refused other available approved therapies and is now a candidate for salvage therapy.
- 1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid tumor malignancy or lymphoma in a participant with disease relapse or progression on an ICI (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective USPI.
- 2. Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 3. Age >18 years old at the time of signing the ICF. 4. Presence of measurable disease by iRECIST or RECIL criteria, assessed before the start of lympho-conditioning and within 28 days prior to Day 1.
Key exclusion criteria (14 listed)
- 1. Females who are pregnant or breastfeeding. 2. ECOG performance status ≥ 2. 3. Evidence of insufficient organ function as determined by any one of the following: 3a. Neutrophils <1000/µL or platelets <75,000/µL. 3b. Estimated creatinine clearance <50 mL/minute (Cockcroft-gault). 3c. Total bilirubin >2 x upper limit normal (ULN) with the exception of participants with Gilbert's Syndrome or known liver metastases.
- 3d. Aspartate aminotransferase (AST) >3 x ULN, or alanine aminotransferase (ALT) >3 x ULN. For participants with known liver metastases, AST or ALT >5 x ULN.
- 3e. Oxygen saturation <90% on room air. 3f. Left ventricular ejection fraction (LVEF) <40% (eg by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan).
- 4.Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation) within 2 weeks prior to Day 1. Participants in Regimen B currently taking an ICI must interrupt ICI dosing at least 2 weeks prior to Day 1.
- 5. CNS metastases that have not been treated; or treated CNS metastases that have not been stable for at least 4 weeks.
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 |
|---|---|---|
| FT500FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 Monotherapy, FT500 in Combination with Immune Checkpoint Inhibitor |
| NivolumabAlso: OPDIVOImmune Checkpoint Inhibitor | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 in Combination with Immune Checkpoint Inhibitor |
| PembrolizumabAlso: KEYTRUDAImmune Checkpoint Inhibitor | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 in Combination with Immune Checkpoint Inhibitor |
| AtezolizumabAlso: TECENTRIQImmune Checkpoint Inhibitor | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 in Combination with Immune Checkpoint Inhibitor |
| CyclophosphamideLympho-conditioning agent | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 Monotherapy, FT500 in Combination with Immune Checkpoint Inhibitor |
| FludarabineLympho-conditioning agent | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor, FT500 Monotherapy, FT500 in Combination with Immune Checkpoint Inhibitor |
| IL-2Also: Proleukin, AldesleukinBiologic response modifier | Drug | FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor |
Primary outcome
The incidence of participants with Dose Limiting Toxicities (DLTs) within each dose level cohort.
Time frame: Day 29
The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).
2 secondary outcomes
Objective-response rate (ORR)
Time frame: Day 29 and every 8 weeks thereafter through Day 366
Duration of FT500 persistence
Time frame: Day 1 through Day 366
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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
FateTrialDisclosure@fatetherapeutics.com
4 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 FT500, Nivolumab and Pembrolizumab in people with Advanced Solid Tumors 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 1 May 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants with Dose Limiting Toxicities (DLTs) within each dose level cohort. (time frame: Day 29). 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 1 May 2023.