T Cell Receptor Based Therapy of Metastatic Colorectal Cancer

NCT03431311 | Terminated Phase 1

• 1 other identifier: TCR-CRC-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)

Conditions

Colorectal Cancer

Keywords

MSI

Outcome Measures

Primary Outcomes (1)

• Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0

  Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0

  2 years

Secondary Outcomes (3)

• Progression free survival (PFS)

  2 years

• Radiological response rate (ORR)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Adoptive Cell Therapy (ACT)

EXPERIMENTAL

The ACT will be administered as two intravenous (i.v.) injections of GMP TCR T cells per week for 6 weeks. Escalating dose per week, from 1 x108 cells (week 1) to 2x109 cells (week 4 onwards) using a central venous catheter. The doses listed indicate the maximum number of T cells per injection at any given time point.

Biological: Adoptive Cell Therapy (ACT)

Interventions

Adoptive Cell Therapy (ACT) BIOLOGICAL

T cell receptor based therapy of metastatic colorectal cancer with mRNA-engineered T cells targeting mutant transforming growth factor beta receptor type II (TGFβII)

Adoptive Cell Therapy (ACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic colon cancer which is MSI+ with the presence of the -1A deletion in TGFβRII gene, and positive for HLA-A02 genotype
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
• Age 18 years and older
• Life expectancy of at least 3 months
• Signed informed consent (by the subject or subject's legal representative) obtained before any trial-related procedures.
• Adequate organ function, measured by pre-defined laboratory values

You may not qualify if:

• Other metastatic malignancies
• Any other anti-tumour treatment within 4 weeks prior to first administration of cells.
• Steroid treatment, except substitution dose
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina or serious cardiac arrhythmia
• Active infection requiring antibiotic therapy
• Pregnancy or lactation
• Known hypersensitivity to any of the components of the investigational product
• Patients who test positive for hepatitis B, C, HIV or syphilis
• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0379, Norway

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Svein Dueland, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 13, 2018
• Study Start: March 8, 2018
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

NO (1)