FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
NCT05395052 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2023-09-21
Summary
This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Conditions
- Non Small Cell Lung Cancer
- Colorectal Cancer
- Breast Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Head and Neck Cancer
- GastroEsophageal Cancer
Interventions
- DRUG
-
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
- DRUG
-
Lympho-conditioning agent
- DRUG
-
Lympho-conditioning agent
- DRUG
-
IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
- COMBINATION_PRODUCT
-
Avelumab
Monoclonal antibody
- COMBINATION_PRODUCT
-
Pembrolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
- COMBINATION_PRODUCT
-
Nivolumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
- COMBINATION_PRODUCT
-
Atezolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
- COMBINATION_PRODUCT
-
Trastuzumab
Monoclonal antibody
- COMBINATION_PRODUCT
-
Cetuximab
Monoclonal antibody
- COMBINATION_PRODUCT
-
Amivantamab
Monoclonal antibody
- DRUG
-
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Fate Trial Disclosure · Fate Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-31
- Primary Completion
- 2023-08-11
- Completion
- 2023-08-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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