TCR1188-ABC Cells for KRAS-Mutated Cancers

Overseen By Abramson Cancer Center Clinical Trials Service

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Must not be taking: Systemic steroids, Immunosuppressants

Disqualifiers: Hepatitis, HIV, Cardiovascular disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, TCR1188-ABC cells (a type of cell therapy), for cancers with a specific KRAS mutation. The goal is to determine if these cells are safe and effective for individuals with certain advanced cancers, such as pancreatic, colorectal, and lung cancer. Participants must have a confirmed KRAS G12V mutation and have previously tried other cancer treatments. The trial will test different doses to identify the safest and most effective amount. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroids or immunosuppressants, you may need to adjust or stop them, as these are generally not allowed unless they are low-dose or topical.

Is there any evidence suggesting that TCR1188-ABC cells are likely to be safe for humans?

Research has shown that TCR1188-ABC cells, a treatment under study for certain cancers, appear safe. In a study with a similar treatment for a specific cancer mutation, patients with pancreatic cancer reported no serious side effects, regardless of the dose. This suggests that treatments like TCR1188-ABC cells might be well-tolerated.

Please note, this trial is in its early stages. The primary aim is to find a safe dose and identify any side effects. So far, the data suggests a good safety profile, but further research is needed to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care options for KRAS-mutated cancers, which often involve chemotherapy and targeted therapies, TCR1188-ABC cells offer a novel approach by using engineered T-cells to target cancer cells directly. This treatment is exciting because it leverages a patient's own immune system to recognize and attack tumors with a specific mutation, potentially leading to more precise and effective results. Researchers are particularly interested in how these cells can be administered in varying doses, seeking the most effective and safest level for patients.

What evidence suggests that TCR1188-ABC cells might be an effective treatment for KRAS-mutated cancers?

Research has shown that TCR-T therapies targeting the KRAS G12V mutation hold promise, with some patients experiencing significant improvements. KRAS mutations can promote cancer growth and help tumors evade the immune system. TCR1188-ABC cells, administered to participants in this trial at varying dose levels, are designed to directly attack these mutations, potentially preventing cancer from spreading. Early trials of similar treatments showed positive results, suggesting these cells might slow down or shrink tumors in patients with KRAS-mutated cancers, such as pancreatic and colorectal cancer. Although further research is necessary, these findings offer hope for new treatment options. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic, bile duct, colorectal, or non-small cell lung cancer that have a specific KRAS G12V mutation. Participants must have cancer that has spread and meet certain health requirements.

Inclusion Criteria

I have been diagnosed with metastatic pancreatic or bile duct cancer.

I have metastatic colorectal cancer confirmed by biopsy.

I have been diagnosed with metastatic non-small cell lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TCR1188-ABC cells at varying dose levels to assess safety and efficacy

28 days

Primary Follow-up

Participants are monitored for treatment-related adverse events and dose-limiting toxicities

Up to 15 years

Extended Follow-up

Long-term monitoring for overall survival and progression-free survival

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

• TCR1188-ABC cells

Trial Overview

Researchers are testing TCR1188-ABC cells (a type of engineered immune cell) after giving patients chemotherapy drugs fludarabine and cyclophosphamide. Tocilizumab may also be used to manage side effects. The study aims to find the safest dose.

How Is the Trial Designed?

Group I: Dose level 3 Experimental Treatment 3 Interventions

3 x 10\^9 TCR1188-ABC cells

Group II: Dose level 2 Experimental Treatment 3 Interventions

1 x 10\^9 TCR1188-ABC cells

Group III: Dose level 1 Experimental Treatment 3 Interventions

3.33 x 10\^8 TCR1188-ABC cells

Group IV: Dose level -1 Experimental Treatment 3 Interventions

1.11 x 10\^8 TCR1188-ABC cells

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

ctv.veeva.com

ctv.veeva.com/study/tcr1188-abc-cells-in-kras-mutated-cancers

TCR1188-ABC Cells in KRAS-mutated Cancers

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07594067

TCR1188-ABC Cells in KRAS-mutated Cancers

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11899378/

KRAS Mutations in Cancer: Understanding Signaling ... - PMC

KRAS mutations promote oncogenic signaling and modify the tumor microenvironment (TME), promoting immune evasion and tumor growth.

4.

dailyreporter.esmo.org

dailyreporter.esmo.org/esmo-congress-2025/immunotherapy/first-in-human-trial-of-a-tcr-t-therapy-targeting-kras-g12v-reports-a-significant-response-rate

TCR-T therapy targeting KRAS G12V shows significant ...

First-in-human trial of a TCR-T therapy targeting KRAS G12V reports a significant response rate. 20 Oct 2025 Pancreatic Adenocarcinoma Colon and ...

5.

onclive.com

onclive.com/view/investigators-explore-the-role-of-vs-6766-and-defactinib-in-kras-mutant-nsclc

Investigators Explore the Role of VS-6766 and Defactinib ...

Patients with non-small cell lung cancer (NSCLC) harboring KRAS mutations have been an underserved population with few treatment options, ...

6.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/NT-112-301/

Phase 1 Study to Investigate TCRTs KRAS Mutation in ...

This is a Phase 1, open-label, Phase 1, Multi-Center Master Protocol to evaluate the safety and preliminary Anti-Tumor activity of TCR-Engineered T cells (KRAS ...