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New cell therapy aims to train immune system against hard-to-treat cancers

NCT ID NCT07396090

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early study tests a new treatment called CAT-101, which uses a patient's own immune cells (dendritic cells) loaded with a cancer protein (mKRAS) to help the body fight tumors. It is for people with advanced pancreatic cancer or other solid tumors that have a specific KRAS mutation. The treatment is given alone or with another drug (tislelizumab) that boosts the immune response. The main goals are to check safety and see if the treatment shrinks tumors.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 75 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:(1)Age 18-75 years,Male or female ; (2)Participants with ECOG score of 0-1 and the life expectancy ≥6 months; (3)Sufficient organ function as defined by the following criteria: creatinine clearance of ≥45 mL/min;Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert syndrome, the direct bilirubin may be ≤1.5 × ULN); for patients with liver and/or bone metastases, alkaline phosphatase ≤5.0 × ULN; Left ventricular ejection fraction ≥45% (by echocardiography or MUGA) (4) pregnancy test for women must be negative, and or must not be breastfeeding; participants with childbearing potential must agree to use effective contraception from the signing of the informed consent form until 1 year after the use of the study drug; (5) Willing to sign the informed consent form (ICF); (6)HLA-A\*1101+ Participants with histologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.) and harboring at least one of the targeted KRAS mutants (G12C/D/R/V); (7)Participants who have failed standard treatment or who have no standard treatment options or who have minimal residual disease (MRD) after standard treatment , as well as those have unresectable locally advanced or metastatic solid tumors but currently unsuitable for standard treatment. (8) Participants must have measurable lesions detected by computed tomography (CT) or magnetic resonance imaging (MRI) (according to iRECIST criteria); \- Exclusion Criteria:(1) Patients received other investigational therapy or any chemotherapy, hormonal therapy, targeted therapy, epigenetic therapy, or treatment with invasive investigational medical devices within 4 weeks or 5 half-lives prior to the first vaccination (whichever is shorter): (2)Patients received proteasome inhibitors and immunomodulators, radiotherapy, or approved Chinese traditional medicine within 2 weeks or 5 half-lives prior to the first vaccination(whichever is shorter), (3) patients with meningeal, brainstem, or spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Participants with asymptomatic brain metastases within 4 weeks before the first vaccination and who do not require steroid treatment for at least 14 days are eligible for enrolment. (4) patients with active second primary malignancy; however, patients received curative treatment and without known active disease for ≥2 years or non-melanoma skin cancer patients who received adequately treatment and with no evidence of disease will be eligible for study entry (5) patients with severe uncontrolled infection (bacterial, viral, fungal, etc.) during the screening period; (6) known positive test results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range or positive for human immunodeficiency virus (HIV) antibody; positive syphilis test within 6 months prior to the vaccinations. (7)Patients with symptomatic heart failure or other cardiac diseases such as severe arrhythmias: * New York Heart Association (NYHA) Class III or IV congestive heart failure; * Myocardial infarction or coronary artery bypass graft (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF; * Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding vasovagal or dehydration-related causes); * History of severe non-ischemic cardiomyopathy; (8)patients with other diseases, including: * Primary immunodeficiency; * Stroke or seizure within 6 months prior to screening; * Significant clinical evidence of dementia or altered mental status; * Parkinson's disease or Parkinson-like movement disorders or history thereof; * Uncontrolled hypothyroidism or hyperthyroidism; (9)Surgery within 2 weeks prior to the vaccination or planned surgery within 2 weeks after the vaccination, excluding local anesthesia; (10)Uncontrolled hypertension, hypercalcemia, or diabetes; (11)Vaccination with live attenuated vaccines within 1 month prior to the first infusion; (12) Patients who have undergone long-term systemic corticosteroid therapy; (13)Known severe allergic reactions to eDC products or their formulation components (e.g., albumin, IL-2) (14)eDC-KRAS preparation failed; (15)Researchers believe that other reasons are not suitable for clinical trials

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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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. A doctor treating you

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More trials for these conditions

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