FT538 in Subjects With Advanced Hematologic Malignancies
NCT ID: NCT04614636
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
42 participants
INTERVENTIONAL
2020-10-17
2023-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FT538 Monotherapy
FT538 monotherapy in subjects with r/r AML
FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Cyclophosphamide
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
FT538 in Combination with Daratumumab
FT538 in combination with daratumumab in subjects with r/r MM
FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Cyclophosphamide
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Daratumumab
Monoclonal Antibody, CD38, Anti-CD38
FT538 in Combination with Elotuzumab
FT538 in combination with elotuzumab in subjects with r/r MM
FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Cyclophosphamide
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Elotuzumab
Monoclonal Antibody
Interventions
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FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Cyclophosphamide
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Daratumumab
Monoclonal Antibody, CD38, Anti-CD38
Elotuzumab
Monoclonal Antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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. Agreement to comply with study procedures as described in the Schedule of Activities
4. Agrees to contraceptive use as described in the protocol
Exclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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Fate Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Fate Trial Disclosure
Role: STUDY_DIRECTOR
Fate Therapeutics, Inc
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Countries
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Other Identifiers
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FT538-101
Identifier Type: -
Identifier Source: org_study_id
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