Clinical trial · Interventional
FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
NCT04551885CI-TRIAL-00069713terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated by the Sponsor.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| FT516 | Drug | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FT516 in combination with avelumab
- interventionNames
- Drug: FT516
- Drug: Avelumab
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: IL-2
Primary outcomes (2)
- measure
- Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
- timeFrame
- Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab * Capable of giving signed informed consent * Aged ≥ 18 years old * Willingness to comply with study procedures and duration * Measurable disease per iRECIST * Contraceptive use for women and men as defined in the protocol Exclusion Criteria: * Pregnant or breast-feeding women * ECOG performance status ≥ 2 * Evidence of insufficient organ function * Clinically significant cardiovascular disease * Receipt of therapy 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 * Known active central nervous system (CNS) involvement by malignancy * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions * Currently receiving or likely to require immunosuppressive therapy * Known active infections with Hepatitis B, Hepatitis C or HIV * Live vaccine within 6 weeks prior to start of lympho-conditioning * Known allergy to albumin (human) or DMSO
References
Publications (1)
- BACKGROUNDZhu 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. PMID 31856277