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Engineered immune cells take on Hard-to-Treat cancers in early trial

NCT ID NCT06767046

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a personalized cell therapy for people with advanced colorectal, pancreatic, or lung cancers that have a specific KRAS G12V mutation. The treatment involves taking a patient's own immune T cells, engineering them to recognize and attack cancer cells, and infusing them back. The study aims to check safety and see if the therapy can shrink tumors in just 8 participants 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
KRAS-specific autologous TCR-T cells (CRTKVA11-N04) plus fludarabine, cyclophosphamide, and interleukin-2
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors with the KRAS G12V mutation, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is a very early (Phase 1) and small (8 participants) study focused mainly on safety. The treatment may not shrink tumors, and side effects could be serious, including immune reactions or organ damage.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patients aged 18-70 years. * Histologically or cytologically confirmed advanced solid tumors (e.g., colorectal cancer, pancreatic cancer, NSCLC) with KRAS G12V mutations and HLA-A\*11:01 genotype. * Failed standard therapies or no effective treatment available. * ECOG performance status of 0-1. * Life expectancy of ≥3 months. * Presence of at least one measurable lesion as defined by RECIST 1.1 criteria. * Female patients of childbearing potential must agree to use highly effective contraceptive methods during the study and for at least 6 months after the last dose. A negative pregnancy test within 7 days prior to treatment initiation is required. * Written informed consent provided by the patient, with an expectation of compliance with study procedures. Exclusion Criteria: * 1.Prior treatment with gene-modified T-cell therapies. * Current treatment with T-cell suppressive agents (e.g., cyclophosphamide, FK506, tripterygium glycosides) or T-cell stimulants. * Chemotherapy, targeted therapy, immunotherapy, or investigational drugs administered within 2 weeks, or radiotherapy within 4 weeks prior to enrollment. * Significant organ dysfunction, as evidenced by: * leukocytes\<3.0 x 109/L * absolute neutrophil count \>1.5 x 109/L * hemoglobin\<90g/L * platelets \<100 x 109/L * Creatinine\>1.5×ULN or creatinine clearance \<50mL/min * lymphocytes\<0.5 x 109/L * total bilirubin\>3×ULN; ALT/AST\>3×ULN (or \>5× ULN in patients with liver metastases) * INR/APTT\>1.5×ULN; * SpO2≤93% * Presence of serious diseases and comorbidities, including but not limited to: severe heart disease, cerebrovascular disease, seizures, poorly controlled diabetes (such as Type 1 diabetes or insulin-dependent diabetes), pancreatic dysfunction, severe infections, active gastrointestinal ulcers, gastrointestinal bleeding, mechanical or paralytic bowel obstruction, pulmonary fibrosis, renal failure, respiratory failure, etc. * History of severe cardiovascular diseases within the past 6 months, including but not limited to: myocardial infarction, severe or unstable angina, coronary artery or peripheral artery bypass surgery, New York Heart Association (NYHA) Class III or IV heart failure, etc. * Left ventricular ejection fraction (LVEF) \< 50%. * Symptomatic brain metastases unless stabilized with prior treatment (e.g., surgery or radiotherapy). * Known history of myelodysplastic syndrome, lymphoma, or other malignancies. * Known allergy to albumin, investigational drugs, or their excipients. * Active autoimmune diseases, including but not limited to acquired/congenital immunodeficiency, organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, or inflammatory bowel disease. * Active hepatitis B, hepatitis C, or HIV infection. * Pregnancy or breastfeeding. * Uncontrolled mental or neurological disorders. * Any condition deemed unsuitable for study participation by the investigator.

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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.

Contacts and locations

Locations

  • Capital Medical University Affiliated Beijing Ditan Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.