| Eligibility |
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.
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