Clinical trial · Interventional
T Cell Receptor Based Therapy of Metastatic Colorectal Cancer
Protocol for Treatment Under Hospital Exemption: T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)
NCT03431311CI-TRIAL-00039061TCR-CRC-001terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adoptive Cell Therapy (ACT) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adoptive Cell Therapy (ACT)
- description
- 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.
- interventionNames
- Biological: Adoptive Cell Therapy (ACT)
Primary outcomes (1)
- measure
- Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
- timeFrame
- 2 years
- description
- Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
Secondary outcomes (3)
- measure
- Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Female or male patients. Fertile females must have a negative pregnancy test before inclusion in the trial. Both fertile men and women must be ready and able to use highly effective methods of contraception, defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy during participation of the trial * 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 Exclusion criteria * 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
References
Publications (1)
- DERIVEDMaggadottir SM, Dueland S, Mensali N, Hamre H, Andresen PA, Myhre MR, Juul HV, Bigalke I, Lundby M, Honnashagen TK, Saeboe-Larssen S, Josefsen D, Hagtvedt T, Walchli S, Kvalheim G, Inderberg EM. Transient TCR-based T cell therapy in a patient with advanced treatment-resistant MSI-high colorectal cancer. Mol Ther. 2024 Jun 5;32(6):2021-2029. doi: 10.1016/j.ymthe.2024.04.009. Epub 2024 Apr 6. PMID 38582964