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This study was terminated by the Sponsor.
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This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT516 in combination with avelumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT516 | Drug | Experimental Interventional Therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort | The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells. | Up to Day 29 after the end of Cycle 1 (each cycle is 28 days) |
| Severity of DLTs Within Each Dose Level Cohort | The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells. | At the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with ≥1 Adverse Events (AE) | An AE is any untoward medical occurrence in a participants temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 15 years |
| Investigator-Assessed Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fate Trial Disclosure | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States | ||
| Hackensack University Medical Center/John Theurer Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31856277 | Background | Zhu H, Blum RH, Bjordahl R, Gaidarova S, Rogers P, Lee TT, Abujarour R, Bonello GB, Wu J, Tsai PF, Miller JS, Walcheck B, Valamehr B, Kaufman DS. Pluripotent stem cell-derived NK cells with high-affinity noncleavable CD16a mediate improved antitumor activity. Blood. 2020 Feb 6;135(6):399-410. doi: 10.1182/blood.2019000621. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D015266 | Carcinoma, Merkel Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Avelumab |
| Drug |
Monoclonal antibody |
|
|
| Cyclophosphamide | Drug | Lympho-conditioning agent |
|
| Fludarabine | Drug | Lympho-conditioning agent |
|
| IL-2 | Drug | Biologic response modifier |
|
|
DOR is the time from the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per modified Response Evaluation Criteria in Solid Tumors (iRECIST) response criteria. |
| Up to 15 years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria. | Up to 15 years |
| Progression Free Survival (PFS) | PFS is defined as the time from first dose of lympho-conditioning to disease progression or to the day of death for any reason, whichever occurs first, per iRECIST response criteria. | Up to 15 years |
| Overall Survival (OS) | OS is defined as the time from first dose of lympho-conditioning to death from any cause. | Up to 15 years |
| Determination of PK of FT516 in peripheral blood | The pharmacokinetics of FT516 in peripheral blood will be reported as the relative percentage of product (FT516) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points | Study Days 1, 2, 4, 8, 11, 18, 22, 29 |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |