FT516 in Subjects With Advanced Hematologic Malignancies


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 of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2.
  • Evidence of insufficient organ function.
  • Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1.
  • Currently receiving or likely to require systemic immunosuppressive therapy.
  • Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy.
  • Receipt of an allograft organ transplant.
  • Known active central nervous system (CNS) involvement by malignancy.
  • Clinically significant cardiovascular disease.
  • Clinically significant infections including:
    • Known HIV infection;
    • Known active hepatitis B (HBV) or hepatitis C (HCV) infection;
    • Live vaccine <6 weeks prior to start of conditioning;
    • Known allergy to human albumin and DMSO;
    • QTc > 450 msec on screening ECG.

Additional Exclusion Criteria for Regimen A (FT516 monotherapy):

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

Additional Exclusion Criteria for Regimens B, B1, and B2

  • Diagnosis of Waldenstrom macroglobulinemia.

Eligibility last updated 9/22/21. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Januario Castro, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015


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