MCC1 TCR / Fred Hutchinson Cancer Center, Affini-T Therap, Regeneron - LARVOL DELTA

ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - P1/2 | N=7 | Terminated | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Jan 2025 ➔ Jan 2024 | Active, not recruiting ➔ Terminated; Terminated due to insufficient funding

Immune cell • Metastases • Trial completion date • Trial termination • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • HLA-A

ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - P1/2 | N=7 | Active, not recruiting | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Active, not recruiting | N=16 ➔ 7 | Trial completion date: Apr 2025 ➔ Jan 2025 | Trial primary completion date: Apr 2024 ➔ Jan 2024

Enrollment change • Enrollment closed • Immune cell • Metastases • Trial completion date • Trial primary completion date • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • HLA-A

ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Apr 2024

Immune cell • Metastases • Trial completion date • Trial primary completion date • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • HLA-A

ATTAC-MCC: Phase I/II study of autologous CD8+ and CD4+ transgenic T cells expressing a high affinity MCPyV-specific TCR combined with checkpoint inhibitors and class I MHC-upregulation in patients with metastatic MCC refractory to PD-1 axis blockade. (ASCO 2022) - P1/2 | " NCT03747484 is an ongoing phase I/II, open label, investigator-initiated trial (IIT) of FH-MCVA2TCR in combination with an anti-PD-(L)1 checkpoint inhibitor and an agent to upregulate MHC-I expression on tumor cells...Secondary/exploratory objectives include cellular kinetics of TCR T cells, T cell phenotype, tumor infiltration kinetics, and MHC-I expression dynamics over time. After the first 12 months, patients transition to a long-term follow-up (LTFU) study for up to 15 years as per FDA guidelines."

Checkpoint inhibition • Clinical • IO biomarker • P1/2 data • Genetic Disorders • Immune Modulation • Inflammation • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CD4 • CD8

Clinical Strategy for Enhancing Affini-T Therapeutics’ Merkel Polyoma Virus TCR Therapy to be Presented at ASCO 2022 (Businesswire) - "Affini-T Therapeutics...announced that the clinical strategy for enhancing the efficacy of its Merkel cell polyomavirus (MCPyV)-specific T cell receptor (TCR) program for the treatment of PD-1 refractory Merkel cell carcinoma (MCC), from its strategic collaboration with Fred Hutchinson Cancer Center, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022....'The clinical strategy to be presented at ASCO is the result of tumor biopsy analyses generated from treating MCC patients and reflects the recent addition of an MHC-I boosting molecule to the MCPyV-specific T cell Phase I/II study protocol'."

Clinical protocol • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Oct 2023 ➔ Dec 2025 | Trial primary completion date: Oct 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor • HLA-A