A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

Paused · Phase 1

Conditions studied: Solid Tumor

In brief

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

Key facts

Study ID

NCT03970382

Run by

PACT Pharma, Inc.

People needed

21

Starts

2019-07-03

Expected to finish

2022-08-12

Last updated by the study team

2022-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Northwestern University Medical Center — Chicago, Illinois, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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