FT516 in Subjects With Advanced Hematologic Malignancies

Overview

NCT ID: NCT04023071
Sponsor Protocol Number: FT516-101

About this study

The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Diagnosis of the following:

Regimen A (FT516 monotherapy):

  • Primary Refractory AML.
  • Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required.

Regimen B, B1, and B2  (FT516 + rituximab or obinutuzumab):

  • Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.

All subjects:

  • Willingness to provide informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
  • Age ≥ 18 years old.
  • Stated willingness to comply with study procedures and duration.
  • Presence of measurable disease.
  • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.

Exclusion Criteria:

All subjects:

  • Females who are pregnant or breastfeeding 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2.
  • Evidence of insufficient organ function as determined by any one of the following: a. Neutrophils and platelets:
    • AML: No count restrictions for neutrophils or platelets;
    • Lymphoma: Neutrophils 1.5 × upper limit normal (ULN), not applicable for subjects with Gilbert’s syndrome;
    • AST >3 × ULN or ALT >3 × ULN, not applicable if determined to be directly due to underlying malignancy.
    • NOTE: Subjects who have a laboratory blood test value that is exclusionary per exclusion criteria 3a, 3b, 3c, or 3d are permitted one repeat test, and if no longer exclusionary, may continue to enroll;
    • Oxygen saturation < 92% on room air Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation, rituximab, or obinutuzumab) within 2 weeks prior to Cycle 1 Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1;
    • For subjects with r/r AML, maintenance hydroxyurea for blast control up to the initiation of conditioning is permitted.
  • Currently receiving or likely to require systemic immunosuppressive therapy; e.g., prednisone > 5 mg daily, for any reason from first dose of study treatment through last planned dose of FT516, with the exception of corticosteroids as a pre-medication required for cyclophosphamide, fludarabine, rituximab and/or obinutuzumab.
  • Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy.
  • Prior NK-cell therapy for the disease under study.
  • Receipt of an allograft organ transplant.
  • Known active central nervous system (CNS) involvement by malignancy.
  • Subjects with prior CNS involvement with their malignancy must have completed effective treatment of their CNS disease with at least stable findings on relevant CNS imaging or no evidence of disease based on evaluation of cerebrospinal fluid (CSF). AML subjects with known prior history of CNS involvement should have a lumbar puncture as part of eligibility screening.
  • Clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment, unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher, or cardiac ejection fraction < 40%.
  • Clinically significant infections including: a. Known HIV infection b. Known active hepatitis B (HBV) or hepatitis C (HCV) infection; documented serologic or PCR results are not required for study enrollment
  • Live vaccine <6 weeks prior to start of conditioning.
  • Known allergy to the following FT516 components: albumin (human) or DMSO.
  • Presence of any medical or psycho-social issues that are likely to interfere with safe study conduct, or that may cause increased risk to subject.
  • 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.
  • Subjects 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 Criterion for Regimen A -  FT516 Monotherapy:

  • Diagnosis of promyelocytic leukemia with t(15;17) translocation.

Additional Exclusion Criterion for Regimens B, B1, and B2:

  • Diagnosis of Waldenstrom macroglobulinemia Additional.

Exclusion Criterion for Regimen B2:

  • Prior bendamustine therapy.

Eligibility last updated 2/22/22. Questions regarding updates should be directed to the study team contact.

More information

Publications

Publications are currently not available