Table 2.

Clinical studies of adoptive transfer of antigen-specific TCR-T cells against AML.

Identifier	TCR-T therapy	Leukemia	Phase	Outcome measures	Status	Locations
NCT02550535	Autologous WT1 TCR-T cells	■ Myelodysplastic syndromes; ■ Acute myeloid leukaemia	Phase 1	■ Safety following gene-modified WT1 TCR T-cell therapy as measured by suspected unexpected serious adverse reactions (SUSARS); ■ Proportion of subjects achieving 1 or more IWG response criteria following gene-modified WT1 TCR T-cell therapy; ■ Safety and tolerability of gene-modified WT1 TCR therapy as measured by clinical laboratory parameters and adverse events. ■ Among 10 patients (6 AML, 3 MDS, and 1 TKI-resistant CML) enrolled in the study, All 6 AML patients survived, at last, follow-up (median 12 months) and median 3 months in the 3 patients with MDS. 3 deaths: 2 from disease progression and 1 from other causes.	Completed	■ AZ St. Jan Brugge-Oostende AV Brugge, Belgium ■ UZ Leuven Leuven, Belgium ■ Uniklinikum Dresden, Germany
			Phase 2
UMIN00001159	Autologous WT1 siTCR-T cells	■ Acute myeloid leukemia; ■ Myelodysplastic syndromes	Unknown	■ No adverse events of normal tissue were seen. ■ 2 patients showed transient decreases in blast counts in bone marrow, which was associated with recovery of hematopoiesis.	Completed	■ Mie University Hospital, Japan ■ Ehime University Hospital, Japan ■ Fujita Health University Hospital, Japan ■ Nagoya University Hospital, Japan
NCT01621724	Autologous WT1 TCR-T cells	■ Acute myeloid leukemia; ■ Chronic myeloid leukemia	Phase 1	■ Identify organ toxicities and other side effects ■ Transduction efficiency and TCR expression on TCR-transduced cells ■ WT1-specific immune responses of TCR-transduced T cells	Completed	■ University Hospitals Bristol NHS Foundation Trust Bristol, UK ■ University College London Hospitals NHS Trust London, UK, NW1 2PG
			Phase 2
NCT01640301	Allogeneic WT1 TCR-T cells	■ Recurrent adult acute myeloid leukemia; ■ Recurrent childhood acute myeloid leukemia; ■ Secondary acute myeloid leukemia	Phase 1	■ Antileukemic potential efficacy, in terms of duration of response (Arm II). ■ Efficacy, in terms of relapse rate (Arm I). ■ Incidence of chronic graft versus host disease (GVHD) (Arm I).	Active, not recruiting	■ Fred Hutch University of Wash ington Cancer Consortium Seattle, Washington, USA
			Phase 2
NCT04284228	Allogeneic WT1/PRAME/Cyclin A1-antigen-specific CD8+ T cells (NEXI-001 T-cell product)	■ Acute myeloid leukemia; ■ Myelodysplastic syndrome	Phase 1	■ Adverse events of special interest (AESIs) events of dose-limiting toxicities (DLTs) ■ AESI events of infusion-related reactions and cytokine release syndrome (CRS) ■ Survival, including median progressive-free survival (PFS), overall response rate (ORR), overall survival (OS).	Recruiting	■ City of Hope Comprehensive Cancer Center Duarte, California, USA ■ Advent Health Medical Group Blood & Marrow Transplant Orlando, Florida, USA ■ Karmanos Cancer Institute Detroit, Michigan, United States
			Phase 2
NCT03503968	Autologous PRAME TCR-T cells (MDG1011 cell product)	■ High-risk myeloid; ■ Lymphoid neoplasms (including relapse AML after allo-HSCT)	Phase 1	■ Adverse events and dose limiting toxicities (safety and tolerability). ■ Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of MDG101. ■ For feasibility: percent of all subjects who receive the planned target dose of MDG1011.	Recruiting	■ University Hospital Dresden, Dresden, Germany ■ University Hospital Erlangen, Erlangen, Germany ■ University Hospital Frankfurt, Frankfurt, Germany
			Phase 2
NCT03326921	Allogeneic HA-1 TCR-T cells	■ Juvenile myelomonocytic leukemia ■ Recurrent acute biphenotypic leukemia ■ Recurrent acute undifferentiated leukemia	Phase 1	■ Feasibility of manufacturing minor H antigen (HA-1) T-cell receptor (TCR) CD8+ and CD4+ T cells. ■ Feasibility of administering minor H antigen (HA-1) T-cell receptor (TCR) CD8+ and CD4+ T cells. ■ Incidence of dose-limiting toxicities of HA-1 T-cell receptor (TCR) T cells.	Recruiting	■ Fred Hutch University of Washington Cancer Consortium Seattle, Washington, United States
NCT04464889	Autologous HA-1 H TCR-T cells	■ Acute myeloid leukemia ■ Myelodysplastic syndromes	Phase 1	■ Safety and tolerability of HA-1H TCR-transduced T cells: incidence and severity of adverse events. ■ Maximum tolerated dose (MTD) of HA-1H TCR-transduced T cells. ■ Recommended phase 2 doses (RP2D) of HA-1H TCR-transduced T cells.	Active, not recruiting	■ Leiden University Medical Centre Leiden, Zuid Holland, Netherlands