P1, N=44, Recruiting, University of Pennsylvania | Phase classification: P1b --> P1

P2, N=41, Completed, Sellas Life Sciences Group | N=31 --> 41

P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2

P1, N=15, Active, not recruiting, 3D Medicines | Trial primary completion date: May 2024 --> Dec 2024

P1, N=30, Not yet recruiting, Marker Therapeutics, Inc.

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025

P1/2, N=24, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed

P1, N=79, Recruiting, Marker Therapeutics, Inc. | N=37 --> 79

P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P1/2, N=47, Terminated, Sumitomo Pharma America, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Sponsor's decision to terminate development of the program.

P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting

P1/2, N=24, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2027 --> Jun 2024 | Trial primary completion date: Dec 2027 --> Jun 2024

P1/2, N=22, Active, not recruiting, NexImmune Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Oct 2022 --> Oct 2024

P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=59, Completed, Hoffmann-La Roche | Recruiting --> Completed | N=220 --> 59 | Trial completion date: Feb 2026 --> Aug 2023 | Trial primary completion date: Feb 2026 --> Aug 2023

RO7283420 is the first TCR-L TCB antibody evaluated in AML. We observed pharmacodynamic evidence of T-cell activation and expansion in the clinic, in line with the expected MoA of TCBs, however, at the explored doses, no clear exposure-response relationship and only a modest clinical activity were observed. The safety profile was shown to be consistent with the other TCBs and R/R AML population.

P1, N=15, Active, not recruiting, 3D Medicines | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> May 2024

Safety: N=25, GPS alone=8 (due to disease progression); >1 dose of combination =17. Median age: 64-yrs; median number of prior lines: 2. Five patients experienced 11 SAEs, one of which was drug related.

Oral azacytidine may be used as maintenance treatment in AML in first remission, but can be associated with substantial side effects, and less toxic strategies should be explored. OS at five years was 75% (95% CI: 50-89), with 70% of patients ≥60 years of age being long-term survivors. Maintenance therapy with this DC vaccine was well tolerated in AML patients in CR1 and was accompanied by encouraging 5-year long-term survival.

P1, N=220, Recruiting, Hoffmann-La Roche | Suspended --> Recruiting

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024

P1, N=11, Terminated, Mana Therapeutics | N=27 --> 11 | Active, not recruiting --> Terminated; Product manufacturing

P1/2, N=43, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Jun 2023 | Trial primary completion date: Feb 2024 --> Jun 2023

Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity.

P1, N=220, Suspended, Hoffmann-La Roche | Recruiting --> Suspended

Glucose uptake was examined by 2-deoxyglucose uptake assay... GLUT1 is involved in the increase of glucose uptake in ESCs during decidualization. The up-regulation of GLUT1 is mediated by the promoter bindings of C/EBPβ and WT1. Furthermore, both C/EBPβ and WT1 contribute to induce the epigenetic changes of the GLUT1 promoter by recruiting p300.

The results revealed Gallic acid (GA) and Chlorogenic acid (CA) as promising WT1 inhibitors...We found that GA significantly downregulated both these genes compared to CA. Our results suggested that GA is a potential inhibitor of WT1 and might be an excellent anti-LSCs natural drug for AML patients.

P1/2, N=24, Active, not recruiting, Astellas Pharma Global Development, Inc. | N=385 --> 24

Therapy included six (every two weeks) subcutaneous inoculations of galinpepimut-S vaccine adjuvanted with Montanide, low-dose subcutaneous sargramostim at the injection site, with intravenous nivolumab over 12 weeks, and up to six additional doses until disease progression or toxicity. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses, as indicated by immunophenotyping and WT1-specific IgG production. Exploratory analysis for efficacy yielded a promising 1-year PFS rate.

P3, N=221, Completed, Sumitomo Pharma Oncology, Inc. | Active, not recruiting --> Completed

P1/2, N=385, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting

P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

shikonin can down-regulate the WT1 protein level for leukemia differentiation therapy, and 2. the interaction between WT1 and CD34 proteins may be responsible for granulocyte/monocyte immaturity in HL-60 cells.

P1b/2, N=47, Completed, Sumitomo Pharma Oncology, Inc. | Active, not recruiting --> Completed | N=84 --> 47

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

P1b/2, N=84, Active, not recruiting, Sumitomo Pharma Oncology, Inc. | Trial completion date: Feb 2024 --> Nov 2022 | Trial primary completion date: Aug 2023 --> Oct 2022

P1, N=220, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2024 --> Feb 2026 | Trial primary completion date: Oct 2024 --> Feb 2026

In summary, we have developed a novel AIM np-based T cell expansion platform for the rapid, streamlined generation of clinically relevant number of tumor-specific, multi-antigen, memory CD8+ T cells in 14 days. The results reported here support the development of additional multi-institution phase 1 /2 clinical trials of adoptive T cell transfer in hematologic and solid cancers.

P1/2, N=6, Terminated, Intellia Therapeutics | N=54 --> 6 | Trial completion date: Sep 2025 --> Aug 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Jul 2022; Pivoting to an allogeneic version of this program currently in preclinical development.

P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

DSP-7888 Emulsion can promote both cytotoxic and helper T-cell-mediated immune responses against WT1-positive tumors. Adegramotide enhances CTL numbers, and the CTLs induced by treatment with both nelatimotide and adegramotide are capable of functioning within the immunosuppressive tumor microenvironment. The ability of anti-PD-1 to enhance the antitumor activity of DSP-7888 Emulsion in mice implanted with WT1-positive tumors suggests the potential for synergy.