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

PACT Pharma

Status and phase: Suspended; Phase 1

Conditions: Solid Tumor

Treatments: Biological: nivolumab; Biological: NeoTCR-P1 adoptive cell therapy; Biological: IL-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03970382

PACT-0101

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

NeoTCR-P1

Experimental group

Description:

Single dose of NeoTCR-P1

Treatment:

Biological: NeoTCR-P1 adoptive cell therapy

NeoTCR-P1 plus nivolumab

Experimental group

Description:

Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.

Treatment:

Biological: NeoTCR-P1 adoptive cell therapy

Biological: nivolumab

NeoTCR-P1 plus IL-2

Experimental group

Description:

Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.

Treatment:

Biological: IL-2

Biological: NeoTCR-P1 adoptive cell therapy