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Supercharged t cells take on Hard-to-Treat cancers

NCT ID NCT07614048

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This treatment program tests a personalized cell therapy for people with advanced pancreatic or colorectal cancers that have a specific genetic mutation (KRAS G12D). Patients' own immune cells are collected, genetically engineered to recognize and attack the cancer, and then infused back after a short course of chemotherapy. The goal is to control the disease in patients who have run out of standard options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
engineered T cells (TCR-T cells) targeting mutant KRAS
What this could lead to
If successful, this could offer a new treatment option for patients with advanced pancreatic or colorectal cancers that have not responded to standard therapies.
What could go wrong
This is an early-stage expanded access program, not a large controlled trial. The treatment may not shrink tumors or improve survival, and there are risks from chemotherapy and cell infusion, including severe immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed, advanced or metastatic solid tumor with a documented KRAS G12D mutation confirmed by a CLIA-certified assay, and a high-resolution HLA typing demonstrating expression of HLA-A11:01 and/or HLA-C08:02. * Disease-specific prior therapy requirements: 1. Advanced colorectal cancer: prior treatment with fluoropyrimidine-based chemotherapy regimens with exposure to both oxaliplatin and irinotecan. 2. Advanced pancreatic ductal adenocarcinoma: prior treatment with at least one systemic regimen, including either a fluoropyrimidine-based regimen (e.g., FOLFIRINOX), or a gemcitabine-based regimen (gemcitabine with nab-paclitaxel, or gemcitabine with cisplatin). 3. Advanced non-small cell lung cancer: prior receipt of at least one line of therapy including a PD-1 or PD-L1 inhibitor, with or without platinum-based chemotherapy. 4. Advanced esophageal/gastroesophageal/gastric adenocarcinoma: patients are required to have received at least one line of fluoropyrimidine-based chemotherapy. For tumors harboring HER2 amplifications, prior treatment with at least one HER2-targeted therapy is required. For tumors with combined positive score (CPS) or 1 or higher, prior treatment with immune checkpoint inhibitor is required. 5. Advanced small bowel adenocarcinoma: patients are required to have received fluoropyrimidine-based chemotherapy regimens containing oxaliplatin and irinotecan. 6. Advanced appendiceal adenocarcinoma: patients are required to have received fluoropyrimidine-based chemotherapy regimens containing oxaliplatin and irinotecan. 7. Advanced biliary tract adenocarcinoma and periampullary adenocarcinoma: patients are required to have received at least one prior line of therapy. For tumors with FGFR2 fusions, a prior exposure to an FGFR inhibitor is required.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

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  2. The official record

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Contacts and locations

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