HLA-A2 positive

P4, N=250, Recruiting, Emory University | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025

P1/2, N=18, Recruiting, TCRCure Biopharma Ltd. | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P1/2, N=50, Completed, Sabine Mueller, MD, PhD | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Dec 2023 | Trial primary completion date: Nov 2024 --> Dec 2023

P1/2, N=20, Recruiting, Adaptimmune | Not yet recruiting --> Recruiting

P1, N=71, Active, not recruiting, Adaptimmune | N=52 --> 71 | Trial completion date: Sep 2035 --> Sep 2032

P1/2, N=11, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Feb 2023

P1, N=22, Active, not recruiting, Massachusetts General Hospital

P4, N=250, Recruiting, Emory University | Trial completion date: Dec 2025 --> Jun 2024 | Trial primary completion date: Dec 2025 --> Jun 2024

P2, N=43, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> May 2023

P2, N=180, Recruiting, ARCAGY/ GINECO GROUP | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025

As a model TCR, we selected a 1G4 clone that reacts with NY-ESO-1-derived peptide in an HLA-A*02-restricted manner... We have successfully designed Platinum TALEN mRNA pairs targeting TRAC and TRBC which facilitate the production of genome-edited human primary T cells. We also developed an electroporation and expansion culture protocol that enables us to produce viable genome-edited 1G4-transduced T cells at a large cell dose equivalent to a clinical scale. Collectively, these results suggest that targeted orthotopic knock-in of antigen-specific TCR-encoding ssDNA into the TCR locus by the use of Platinum TALEN is a promising strategy that can be applied for the clinical manufacturing of therapeutic TCR-T cells.

P1/2, N=18, Recruiting, TCRCure Biopharma Ltd. | Trial primary completion date: Mar 2023 --> Dec 2023

P1, N=22, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1

After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. Contact Information: Greenwich LifeSciences, Inc. Stafford, TX Email: Flamingo-01@greenwichlifesciences.com Website: greenwichlifesciences.com

P1, N=24, Recruiting, James Felker | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=60, Active, not recruiting, James Felker | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=25, Recruiting, James Felker | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

This 3-year analysis supported a continued long-term benefit of tebentafusp for overall survival among adult HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma. (Funded by Immunocore; IMCgp100-202 ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.).

In HLA-A2-positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to CT. Further evaluation in this population is warranted.

P1, N=7, Terminated, GlaxoSmithKline

P2, N=7, Active, not recruiting, GlaxoSmithKline

Consistent with the expression profile of survivin across a broad range of both hematological and solid tumors, treatment of AML and NSCLC cell lines with ABBV-184 results in T cell activation, proliferation, and potent redirected cytotoxicity of HLA-A2 positive target cell lines, both in vitro and in vivo, including patient-derived AML samples. These results indicate that ABBV-184 is an attractive clinical candidate for the treatment of patients with AML and NSCLC.

Conclusions ImmTAC-mediated redirection of T cells reprograms pro-tumoral M2 macrophages towards anti-tumoral M1 macrophages in vitro and in tebentafusp-treated mUM patients. These results demonstrate how tebentafusp re-shapes the tumor microenvironment to enhance the anti-tumor activity of T cells.

After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study has been initiated in the US with plans to open in Europe.

Conclusions HLA-A status predicted clinical outcomes of patients receiving ICB. HLA genotyping could be incorporated early into the diagnostic work-up of patients with solid cancers as a predictive and selective biomarker.

P1, N=5, Terminated, GlaxoSmithKline

P2, N=66, Recruiting, Adaptimmune | Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023

P2, N=45, Active, not recruiting, Adaptimmune | Trial primary completion date: Apr 2023 --> Dec 2023

P1/2, N=22, Completed, University of Washington | Active, not recruiting --> Completed

P=N/A, N=100, Recruiting, Institut Claudius Regaud

P2, N=43, Active, not recruiting, National Cancer Institute (NCI) | N=13 --> 43

After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. The study is also expected to be opened in Spain, Germany, and France. Clinical trial information: NCT05232916.

P2, N=45, Active, not recruiting, Adaptimmune | Recruiting --> Active, not recruiting | Trial completion date: Oct 2038 --> Dec 2023

P1, N=14, Active, not recruiting, Nicholas Butowski | Trial completion date: Dec 2022 --> Dec 2030

After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study has been initiated in the US with plans to open in Europe.

P1/2, N=20, Not yet recruiting, Adaptimmune | Trial completion date: Apr 2038 --> Jun 2038

Funding: This trial is supported by Greenwich LifeSciences. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm.Eligibility Criteria: The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA-A*02; 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy; 3) Exclude Stage IV; and 4) Completed at least 90% of planned trastuzumab-based therapy.Trial Objectives: 1) To determine if GP2 therapy increases IBCFS; 2) To assess the safety profile of GP2; and 3) To monitor immunologic responses to treatment and assess relationship to efficacy and safety.Study Status: The study has been initiated at a number of sites in the US. The study is also expected to be opened in Spain, Germany, and France.

Van Tine, BA et al. Paper 61 presented at: CTOS 2022; Vancouver, BC, Canada.

P1/2, N=9, Terminated, Medigene AG | N=92 --> 9 | Trial completion date: Apr 2024 --> Jul 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Jun 2022; The clinical trial is terminated after the completion of phase I without moving to Phase II.

Neither GSC-lysate nor acid-eluate loading showed enhancement in response of ATCs but the synthetic peptide pool showed significantly increased IFN-γ secretion and increased cytotoxicity towards target cells. These results demonstrate that ATCs activated using a TAA synthetic peptide pool efficiently enhance cytotoxicity specifically to target cells including GSC.

P1, N=11, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting | N=67 --> 11 | Trial completion date: Feb 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Dec 2025

P1b, N=22, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Dec 2021 --> Jun 2023