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BRIEF TITLE: 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

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


  • Org Study ID: PACT-0101
  • Secondary ID:
  • NCT ID: NCT03970382
  • NCT Alias:
  • Sponsor: PACT Pharma, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting July 3, 2019 Phase 1 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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 - Time Frame: 2 years

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

Primary Outcome 3 - Time Frame: 2 years

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

Primary Outcome 4 - Time Frame: 2 years

Condition:

  • Solid Tumor

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Clinical Operations

Phone: 6505979464

Email: clinicaltrials@pactpharma.com

Locations

Facility Status Contact
City of Hope
Duarte, California 91010
United States
Recruiting Ripa Martirosyan, MPH
626-218-2835
hmartirosyan@coh.org
University of California, Los Angeles
Los Angeles, California 90024
United States
Not yet recruiting Bartosz Chmielowski, MD

BChmielowski@mednet.ucla.edu
University of California, Irvine Medical Center
Orange, California 92868
United States
Recruiting UCLA-UCI Alpha Stem Cell Clinic
949-824-3990
stemcell@uci.edu
University of California, Davis
Sacramento, California 95817
United States
Recruiting Mehrdad Abedi, MD
916-734-3772
University of California, San Diego
San Diego, California 92093
United States
Not yet recruiting
University of California, San Francisco
San Francisco, California 94158
United States
Not yet recruiting