KRAS G12D-specific Immune Effector Cells Targeting KRAS G12D-positive Solid Tumors

November 3, 2026 updated by: Shenzhen Geno-Immune Medical Institute

KRAS G12D-specific Engineered Immune Effectors (EIE) Targeting High-risk Tumors With KRAS G12D Mutation

The purpose of this study is to assess the feasibility, safety and efficacy of KRAS G12D-specific engineered immune effector (EIE) therapy in patients with advanced, KRAS G12D-positive malignancies. Another goal of the study is to characterize the function, expansion and persistence of KRAS G12D-specific effector cells in treated patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Important Regulatory Notice:

This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.

ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.

KRAS G12D mutation is one of the most frequent oncogenic drivers in human malignancies including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer and other advanced solid tumors. Patients with metastatic KRAS G12D mutated tumors generally have poor prognosis; after failure of standard chemotherapy, targeted therapy and checkpoint immunotherapy, effective salvage treatment options remain very limited, and overall survival is unsatisfactory. Conventional chemotherapy and existing targeted agents cannot achieve durable tumor control for large proportions of these patients.

The somatic KRAS G12D neoantigen is tumor-specific, absent in normal human tissues, and critical for maintaining malignant phenotypes, which makes it an attractive target for adoptive cell immunotherapy. This trial investigates autologous KRAS G12D-specific EIE therapy. Peripheral blood mononuclear cells (PBMCs) will be collected via leukapheresis and stimulated with autologous dendritic cells primed with KRAS G12D-specific immunogenic peptides. Manufactured EIE products will be phenotypically profiled for CD8+, CD4+ and CD56+ lymphocyte subsets together with antigen specific reactivity. This phase 1/2 study aims to evaluate safety, manufacturing feasibility and preliminary anti-tumor efficacy of autologous KRAS G12D-specific EIEs in subjects with KRAS G12D-positive tumors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lung-Ji Chang, PhD
  • Phone Number: +86 13671121909
  • Email: c@mkgimi.com

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen Geno-immune Medical Institute
        • Contact:
          • Lung-Ji Chang, PhD
          • Phone Number: +86 13671121909
          • Email: c@mkgimi.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Abilities to understand and the willingness to provide written informed consent;
  2. ≥ 18 and ≤ 75 years old;
  3. Histologically confirmed recurrent, refractory or metastatic advanced malignancies with documented KRAS G12D somatic mutation and measurable lesions by RECIST v1.1; patients have progressed after at least one line of standard of care systemic therapy for their malignancy. At time of leukapheresis, patients are either off dexamethasone or receiving dexamethasone ≤ 4 mg/day;
  4. ECOG performance status 0-2 (or Karnofsky performance score ≥ 60);
  5. Life expectancy >3 months;
  6. Satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm^3; hemoglobin > 10 g/dL; platelets > 100000 /mm^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN;
  7. Peripheral blood absolute lymphocyte count must be above 0.8×10^9/L;
  8. Satisfactory heart functions;
  9. Must be willing to follow the instructions of doctors;
  10. Women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.

Exclusion Criteria:

  1. Receipt of KRAS G12D based therapy within 8 weeks prior to study entry;
  2. HIV positive;
  3. Tuberculosis infection not under control;
  4. History of autoimmune disease, or other diseases requiring long-term administration of steroids or immunosuppressive therapies;
  5. History of allergic disease, or allergy to immune cells or study product;
  6. Patients already actively enrolled in other immune cell clinical study;
  7. Presence of untreated or actively progressing central nervous system metastases not locally controlled;
  8. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KRAS G12D-EIEs

Autologous KRAS G12D-specific engineered immune effectors (EIEs)
Biological: KRAS G12D-EIEs

1 to 2 infusions, once a week, for 1x10^5~1x10^7 EIEs/kg via intravenous injection each time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of adverse effects after KRAS G12D-EIE injection
Time Frame: up to one month

To assess the safety of autologous KRAS G12D-EIEs in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
up to one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of successful KRAS G12D-EIE generation
Time Frame: up to one month

The percentage of successful KRAS G12D-EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.
up to one month
Ability of KRAS G12D-EIE cells to induce cancer-specific reactions
Time Frame: : after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion

ELISPOT measurement of target-specific T cells in blood sample
: after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion
Ability of KRAS G12D-EIE cells inducing tumor reduction
Time Frame: after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion

Objective response (complete response (CR) + partial response (PR)) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lesions (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Geno-Immune Medical Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GIMI-IRB-26004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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