FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT03841110 |
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Recruitment Status :
Completed
First Posted : February 15, 2019
Last Update Posted : May 1, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors Lymphoma Gastric Cancer Colorectal Cancer Head and Neck Cancer Squamous Cell Carcinoma EGFR Positive Solid Tumor HER2-positive Breast Cancer Hepatocellular Carcinoma Small Cell Lung Cancer Renal Cell Carcinoma Pancreas Cancer Melanoma NSCLC Urothelial Carcinoma Cervical Cancer Microsatellite Instability Merkel Cell Carcinoma | Drug: FT500 Drug: Nivolumab Drug: Pembrolizumab Drug: Atezolizumab Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) |
| Actual Study Start Date : | February 15, 2019 |
| Actual Primary Completion Date : | November 15, 2022 |
| Actual Study Completion Date : | November 15, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FT500 Monotherapy
FT500 administered once weekly for 3 weeks as a monotherapy
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Drug: FT500
FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy Drug: Cyclophosphamide Lympho-conditioning agent Drug: Fludarabine Lympho-conditioning agent |
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Experimental: FT500 in Combination with Immune Checkpoint Inhibitor
FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
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Drug: FT500
FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy Drug: Nivolumab Immune Checkpoint Inhibitor
Other Name: OPDIVO Drug: Pembrolizumab Immune Checkpoint Inhibitor
Other Name: KEYTRUDA Drug: Atezolizumab Immune Checkpoint Inhibitor
Other Name: TECENTRIQ Drug: Cyclophosphamide Lympho-conditioning agent Drug: Fludarabine Lympho-conditioning agent |
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Experimental: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
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Drug: FT500
FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy Drug: Nivolumab Immune Checkpoint Inhibitor
Other Name: OPDIVO Drug: Pembrolizumab Immune Checkpoint Inhibitor
Other Name: KEYTRUDA Drug: Atezolizumab Immune Checkpoint Inhibitor
Other Name: TECENTRIQ Drug: Cyclophosphamide Lympho-conditioning agent Drug: Fludarabine Lympho-conditioning agent Drug: IL-2 Biologic response modifier
Other Names:
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- 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).
- Objective-response rate (ORR) [ Time Frame: Day 29 and every 8 weeks thereafter through Day 366 ]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.
- Duration of FT500 persistence [ Time Frame: Day 1 through Day 366 ]Duration of FT500 response is defined as duration from Day 1 to undetectable levels of FT500 cells per uL blood.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841110
| United States, California | |
| UCSD Moores Cancer Center | |
| San Diego, California, United States, 92093 | |
| United States, Minnesota | |
| University of Minnesota Masonic Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New Jersey | |
| Hackensack University Medical Center/John Theurer Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Fate Trial Disclosure | FateTrialDisclosure@fatetherapeutics.com |
| Responsible Party: | Fate Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03841110 |
| Other Study ID Numbers: |
FT500-101 |
| First Posted: | February 15, 2019 Key Record Dates |
| Last Update Posted: | May 1, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Carcinoma, Merkel Cell Carcinoma Neoplasms Colorectal Neoplasms Melanoma Carcinoma, Squamous Cell Stomach Neoplasms Head and Neck Neoplasms Small Cell Lung Carcinoma Pancreatic Neoplasms Microsatellite Instability Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms by Site Skin Diseases |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms, Squamous Cell |