AzTrials
AzTrials

Pancreatic CancerPhase 1NCT06487377

IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations

A Phase 1 study testing IX001 TCR-T cells in people with Pancreatic Cancer and Colorectal Cancer, run by Shanghai Pudong Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Cancer, Colorectal Cancer
What is being tested?
IX001 TCR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Jul 2024to Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signing of an informed consent form (ICF);
  • Males or females, aged 18-70 years (inclusive);
  • Pathologically diagnosed with advanced pancreatic cancer or colorectal cancer, having failed or intolerant to at least two lines of standard of care, including metastatic tumors (having received conventional chemotherapy), recurrent tumors (having undergone surgery and adjuvant chemotherapy in the past), or locally advanced tumors with disease progression after neoadjuvant treatment;
  • At least one measurable lesion (according to RECIST1.1[The Response Evaluation Criteria In Solid Tumors] criteria);
  • Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A*11, C*01:02, or C*08:02 subtypes;
  • ECOG (Eastern Cooperative Oncology Group)≤2;
Show all 19Show fewer
  • Life expectancy ≥3 months;
  • Absolute neutrophil count ≥1×10E9/L;
  • Platelet count ≥50×10E9/L, hemoglobin>90g/dL;
  • Absolute lymphocyte count ≥0.5×10E9/L;
  • Adequate functional reserve of organs:
  • Aspartate aminotransferase ≤2.5×ULN (upper limit of normal);
  • Aspartate transaminase ≤2.5×ULN;
  • Creatinine clearance ≥60mL/min;
  • Total serum bilirubin ≤1.5×UNL;
  • The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;
  • No clinically significant electrocardiographic abnormality;
  • Basic oxygen saturation is >92% under the indoor natural air environment.
  • Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion. Contraception must include one highly effective and one additional effective (barrier) method, initiated from screening until at least 1 year after IX001 infusion or until two consecutive flow cytometry tests show the absence of TCR-T cells (whichever occurs later).

Who cannot join

  • Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);
  • A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;
  • Poorly controlled hypertension with drug (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; QTc interval >450 ms for males or QTc interval >470 ms for females during screening (QTc interval calculated using the Fridericia formula);
  • Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleural/peritoneal/pericardial catheter), except any dedicated central venous catheter;
  • A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
  • A positive result obtained in any of the following virological tests:
Show all 24Show fewer
  • Antibody to human immunodeficiency virus (HIV antibody);
  • Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA);
  • Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies;
  • Treponema pallidum antibody (TP antibody); patients may be enrolled after additional examinations are performed to exclude active syphilis where necessary;
  • Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration;
  • Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders;
  • Patients with a history of severe allergy or allergic constitution;
  • A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs in the past 2 years;
  • Interstitial lung disease (such as pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases during screening;
  • History of organ transplantation;
  • Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis;
  • Receipt of gene therapy or other cell therapies with the same target within the past 6 months;
  • Participation in any other clinical trial within 4 weeks prior to signing the informed consent form, or the date of signing the informed consent form still within 5 half-lives of the drug from the last dose in the last clinical trial (whichever is longer);
  • Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan;
  • Patients with contraindications to cyclophosphamide, fludarabine, IL-2, or other drugs related to the study treatment;
  • Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥5 mg/day or other corticosteroids at the equivalent dose) or other immunosuppressive drugs within 12 weeks after the study treatment starts as judged by the investigator;
  • Women who are breastfeeding and are unwilling to stop breastfeeding;
  • Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Clinical Study of IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations

This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled. The study will include 4 dose groups, using a '3+3' dose escalation design.

Read the detailed description

Patients who sign the informed consent form will undergo screening based on inclusion/exclusion criteria. Eligible patients will be enrolled sequentially into dose group 1, dose group -1 or dose group 2, and dose group 3. The procedure of this study is as follows:

(I) The collected peripheral blood mononuclear cells (PBMCs) will be transported to the production workshop for the preparation of IX001. After confirming that IX001 is proved qualified, the investigator will decide whether to start pre-conditioning 5 days before IX001 infusion.

(II) TCR-T cells will be administered via intravenous infusion, and the cell infusion dose will be determined according to the requirements of dose escalation.

(III) Following TCR-T cell infusion, recombinant human interleukin-2 (IL-2) will be continuously injected to assist TCR-T cell growth.

(IV) After TCR-T cell infusion and IL-2 injection are completed, safety and efficacy follow-up visits will be conducted with the subjects until week 96 or until the subject prematurely withdraws from the study.

Being tested
IX001 TCR-T cells
Keywords
KRAS-G12V or G12D
Medical subject headings
Pancreatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IX001 TCR-T cellsBiological

    IX001 TCR-T cell injection will be administered intravenously after lymphodepletion.

Study groups in NCT06487377
Study groupRoleWhat they receive
IX001 TCR-T cellsExperimentalIX001 TCR-T cells targeted for KRAS mutation
Receives: Biological: IX001 TCR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicity (DLT)

    Proportion of patients with DLT

    Measured: 4 weeks

  2. Adverse Events (AEs)

    Incidence and severity of adverse events

    Measured: 96 weeks

  3. Serious Adverse Events (SAEs)

    Incidence and severity of serious adverse events

    Measured: 96 weeks

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1

    Measured: 12 weeks

  2. Disease Control Rate (DCR)

    The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1

    Measured: 12 weeks

  3. Changes in Serum Tumor Markers compared to Baseline

    Changes of tumor markers in serum detected by immunofluorescence compared to baseline level, including carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA), and carbohydrate antigen 12-5 (CA12-5)

    Measured: 12 weeks

  4. Duration of response (DOR)

    DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation as PD or death from any cause

    Measured: 96 weeks

  5. Time to response (TTR)

    TTR is defined as the time between cell infusion and initial disease assessment as CR or PR

    Measured: 96 weeks

  6. Progression-free survival (PFS)

    PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause

    Measured: 96 weeks

  7. Overall survival (OS)

    OS is defined as the time between the date of cell infusion and the death of the patient for any reason

    Measured: 96 weeks

  8. TCR gene copies

    TCR gene copies detected by qPCR in peripheral blood

    Measured: 96 weeks

  9. TCR-T cell counts

    TCR-T cell counts detected by flow cytometry in peripheral blood

    Measured: 96 weeks

  10. Proportion of patients with anti-IX001 antibodies in peripheral blood

    Anti-drug Antibodies

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Study was stopped Sponsor discretion. No patients were dosed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
3+3 dose escalation
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487377
Sponsor's protocol ID
BT003
Status last verified
Aug 2026
First submitted
7 Jun 2024
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IX001 TCR-T cells in people with Pancreatic Cancer and Colorectal Cancer, run by Shanghai Pudong Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicity (DLT) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in