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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
  • NTC 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
    Recruiting
  • Start Date
    July 3, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events as defined as DLTs

Primary Outcome 1 - Timeframe: 28 days

Primary Outcome 2 - Measure: Number of participants with adverse events as a measure of safety and tolerability of NeoTCR-P1 or NeoTCR-P1 in combination with nivolumab

Primary Outcome 2 - Timeframe: 2 years

Primary Outcome 3 - Measure: Maximum Tolerated Dose (MTD) of NeoTCR-P1

Primary Outcome 3 - Timeframe: 2 years

Primary Outcome 4 - Measure: Feasibility of manufacturing NeoTCR-P1

Primary Outcome 4 - Timeframe: 2 years

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: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 6505979464

Email: clinicaltrials@pactpharma.com

LOCATION

Facility Status Contact
Facility: City of Hope
Duarte, California 91010
United States 		Status: Recruiting Contact:
Ripa Martirosyan, MPH
626-218-2835
hmartirosyan@coh.org
Facility: University of California, Irvine Medical Center
Orange, California 92868
United States 		Status: Recruiting Contact:
UCLA-UCI Alpha Stem Cell Clinic
949-824-3990
stemcell@uci.edu
Facility: University of California, Davis
Sacramento, California 95817
United States 		Status: Recruiting Contact:
Mehrdad Abedi, MD
916-734-3772

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