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 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
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
Name: Clinical Operations
Phone: 6505979464
Email: clinicaltrials@pactpharma.com
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 |