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A Phase 1 study of gene-edited autologous neoantigen-targeted TCR-T cells

Daniela Bota

A Study On:

  • Cancer - Oncologic


  • Open


Inclusion Criteria:

Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer.
Disease has progressed after at least one available standard therapy or no additional curative therapies are available.
Measurable disease per RECIST v1.1
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Adequate hematologic and end organ function determined within 30 days prior to enrollment.
Disease-specific criteria related to the specific tumor type are required.
Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Exclusion Criteria:

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease
Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Uncontrolled or symptomatic hypercalcemia
Pregnancy, lactation, or breastfeeding
Prior allogeneic stem cell transplant or solid organ transplant
Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
Active HIV, Hepatitis B, or Hepatitis C infection
Active tuberculosis
Severe infection within 2 weeks prior to enrollment
Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.
Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Interested in joining this trial?

Official Title

A Phase IA/IB, Open-Label First-in-Human Study of the Safety, Tolerability, and Feasibility of Gene-Edited AUtologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination with Anti-PD-1 to Patients with Locally Advanced or Metastatic Solid Tumors

Get in touch with our study team