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

A Phase 1a/1b, 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

INTRODUCTION

  • Org Study ID: PACT-0101
  • Secondary ID: N/A
  • NCT ID: NCT03970382
  • Sponsor: PACT Pharma, Inc.

BRIEF SUMMARY

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.

  • Overall Status
    Suspended
  • Start Date
    July 3, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Solid Tumor

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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