FT538 in Subjects With Advanced Hematologic Malignancies FT538

What's the purpose of this trial?

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  1. Diagnosis of one of the following by treatment regimen:

    Regimen A (FT538 monotherapy in r/r AML)

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

    Regimens B or C (FT538 + mAb in r/r MM)

    • Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
    • Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
    • Regimen B and Regimen C: Measurable disease as defined in the protocol
  2. Capable of giving signed informed consent
  3. Age ≥18 years old
  4. Agreement to comply with study procedures as described in the Schedule of Activities
  5. Contraceptive use as described in the protocol

Exclusion Criteria:

  1. Females who are pregnant or breastfeeding
  2. ECOG Performance Status ≥ 2
  3. Evidence of insufficient hematologic function as defined in the protocol
  4. Evidence of insufficient organ function defined as defined by the protocol
  5. Clinically significant cardiovascular disease as defined by the protocol
  6. Known active central nervous system (CNS) involvement by malignancy
  7. Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
  8. Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
  9. Clinically significant infections including HIV, HBV and HCV
  10. Live vaccine <6 weeks prior to start of lympho-conditioning
  11. Receipt of an allograft organ transplant
  12. Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
  13. Known allergy to albumin (human) or DMSO
  14. Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
  15. Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results

    Exclusion Criteria Specific to Regimen A (r/r AML)

  16. Diagnosis of promyelocytic leukemia with t(15;17) translocation
  17. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1

    Exclusion Criteria Specific to Regimens B and C (r/r MM)

  18. Plasma cell leukemia defined as a plasma cell count >2000/mm3
  19. Leptomeningeal involvement of MM
  20. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb
  21. Allergy or hypersensitivity to antibodies or antibody-related proteins

Additional Trial Information

Phase 1

Enrollment: 105 patients (estimated)

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Trial Locations

All Trial Locations

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University of Minnesota - Masonic Cancer Center University of Minnesota

Minneapolis, MN

Open and Accepting


Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting


Tennessee Oncology Centennial Clinic

Nashville, TN

Open and Accepting


St. David's South Austin Medical Center

Austin, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Methodist Hospital

San Antonio, TX

Open and Accepting
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