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

P

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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