Pancreatic CancerPhase 1IX001 TCR-TNCT06898385

A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation

A Phase 1 study testing IX001 TCR-T injection, Fludarabine and Cyclophosphamide in people with Pancreatic Cancer, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a single-arm, open-label clinical study to evaluate the safety, tolerability and preliminary efficacy of IX001 TCR-T injection in advanced pancreatic cancer patients with KRAS G12V mutation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Cancer
What is being tested?: IX001 TCR-T injection, Fludarabine and Cyclophosphamide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 27 Mar 2025to 27 Sep 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Voluntary signing of an informed consent form (for Human Leukocyte Antigen (HLA) typing and tumor gene mutation test, and main screening)
2. Males or females, aged 18-75 years (inclusive)
3. Patients with pathologically (histopathologically) or cytologically confirmed pancreatic ductal adenocarcinoma
4. Patients with unresectable locally advanced or metastatic disease who fail standard of care, i.e., patients who have progression after prior gemcitabine-containing chemotherapy or FOLFIRINOX (oxaliplatin + irinotecan + calcium folinate + 5-FU) or NALIRIFOX (irinotecan liposome + oxaliplatin + calcium folinate + 5-FU) regimen, including those who have progression within 6 months after the end of neoadjuvant/adjuvant therapy
5. At least one measurable lesion (according to RECIST 1.1 criteria), specifically: longest diameter of ≥10 mm for non lymph node lesions or shortest diameter of ≥15 mm for lymph node lesions (tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable, unless unequivocal progression of the lesion is demonstrated by an evidence)
6. Patients with tumor tissue or peripheral blood tested positive for KRAS-G12V mutation and expression of matching HLA-A*11:01 subtype

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7. Eastern Cooperative Oncology Group (ECOG) ≤ 1
8. Life expectancy ≥3 months
9. Adequate functional reserve of organs: A) Hematology requirements (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): Absolute neutrophil count ≥ 1.5×10^9/L; Platelet count ≥ 75×10^9/L, hemoglobin > 90 g/dL; Absolute lymphocyte count ≥ 0.5×10^9/L; B) Blood Biochemistry Requirements: Alanine aminotransferase ≤ 3 × upper limit of normal（ULN） (≤ 5 × ULN for patients with liver metastases); Aspartate aminotransferase ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min; Serum total bilirubin ≤ 1.5 × ULN; C) Coagulation requirements: Partial thromboplastin activity time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤1.5 × ULN; D) Left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion as diagnosed by echocardiography; E) No clinically significant electrocardiographic abnormality; F) Basic oxygen saturation is >92% under the indoor natural air environment.
10. Women of childbearing age must be negative for blood Human Chorionic Gonadotropin (HCG) 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.

Who cannot join

1. The subject is currently suffered from or have suffered from other incurable malignant tumors within previous 5 years, except in skin basal cell cancer、carcinoma in situ or breast cancer have received curative treatment with no recurrence within the past 3 years)
2. History of organ transplantation
3. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the Informed Consent Forms(ICF)
4. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs
5. Poorly controlled hypertension with drug (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 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)
6. Symptomatic intracranial metastases

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7. Subjects have ascites or pleural effusion requiring drainage to relieve symptoms or have received drainage within 2 weeks. Asymptomatic participants with a small amount of pleural effusion or ascites on imaging are allowed
8. Subjects who have experienced tumor-related intestinal or bowel obstruction within 6 months. including incomplete obstruction related to underlying disease or symptoms of intestinal obstruction requiring treatment
9. 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 within the past 6 months
10. A positive result obtained in any of the following virological tests: A) Antibody to human immunodeficiency virus (HIV antibody); B) Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA); C) 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 ≥2000 IU/mL; D) Treponema pallidum antibody (TP antibody) and positive for unheated serum reagin test;
11. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration
12. Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders
13. Deep vein thrombosis requiring treatment within the past 6 months, unless the risk of thrombosis is acceptable after treatment, as assessed by the investigator
14. Interstitial lung disease (such as interstitial pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases at screening
15. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis
16. Receipt of gene therapy or other cell therapies within the past 6 months
17. Participation in any other clinical studies within 28 days prior to signing the master informed consent form, or the date of signing the master informed consent form still within 5 half-lives of the drug from the last dose in the last clinical study (whichever is longer)
18. 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
19. Patients with contraindications to drugs used in the study
20. 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 after initiation of the study treatment, as judged by the investigator
21. Women who are breastfeeding and are unwilling to stop breastfeeding
22. Any other conditions that are, in the opinion of the investigator, not suitable for enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuhong Li contact

87342487 ext. 020

liyh@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Yuhong, MD, 020-87342487, liyh@sysucc.org.cn
Li Yuhong, MD
Recruiting

Other trials in China

About this study

This is a single-arm, open-label clinical study to evaluate the safety, tolerability and preliminary efficacy of IX001 TCR-T injection in advanced pancreatic cancer patients with KRAS G12V mutation.

Read the detailed description

This study will enroll participants with advanced pancreatic cancer patients with KRAS G12V mutation. The study consists of screening period, leukapheresis period, lymphodepletion period, treatment period, observation period and follow-up period. A total of 9-12 evaluable patients are planned to be recruited. The study is planned to be conducted using the "3 + 3" dose escalation design in two dose groups, and a single dose of the study drug will be administered at the dose levels of 3 × 10^9 ± 30% cells and 1 × 10^10 ± 30% cells. Subjects will be enrolled sequentially and treated by IX001 TCR-T injection at the corresponding planned dose level. All subjects who have received IX001 TCR-T injection will be followed for safety and efficacy up to 2 years.

Conditions: Pancreatic Cancer
Being tested: IX001 TCR-T injection, Fludarabine, Cyclophosphamide
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

IX001 TCR-T injectionBiological
IX001 TCR-T injection will be administered intravenously after lymphodepletion.
FludarabineDrug
Also called Fludara
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Also called Endoxan
Cyclophosphamide is used for lymphodepletion.

Study groups in NCT06898385
Study group	Role	What they receive
IX001 TCR-T injection	Experimental	IX001 TCR-T injection targeted for KRAS mutation Receives: Biological: IX001 TCR-T injection; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

Dose-limiting Toxicity (DLT)
Proportion of patients with DLT
Measured: 4 weeks
Adverse Events (AEs)
Incidence and severity of adverse events
Measured: 2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events
Measured: 2 years

Secondary outcomes (13)

Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Measured: 2 years
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: 2 years
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: 2 years
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 progressive disease (PD) or death from any cause
Measured: 2 years
Time to response (TTR)
TTR is defined as the time between cell infusion and initial disease assessment as CR or PR
Measured: 2 years
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: 2 years
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: 2 years
TCR gene copies
TCR gene copies detected by quantitative polymerase chain reaction (qPCR) in peripheral blood
Measured: 2 years
TCR-T cell counts
TCR-T cell counts detected by flow cytometry in peripheral blood
Measured: 2 years
Pharmacodynamic of IX001 TCR-T injection
Peak TCR-T cell count (Cmax), Time to peak (Tmax) ,Area under the peripheral blood concentration versus time curve (AUC)
Measured: 2 years
Changes in cytokine level
Calculate the change of cytokine level in peripheral blood after IX001 TCR-T injection infusion. Cytokines include interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ), etc
Measured: 2 years
Changes in lymphocyte subpopulations
Calculate the change of lymphocyte subpopulations in peripheral blood by flow cytometry after IX001 TCR-T injection infusion. lymphocyte subpopulations include CD3+T cell, CD4+T cell,CD8+T cell, etc
Measured: 2 years
Proportion of patients with anti-IX001 antibodies
Anti-IX001 TCR-T injection Antibodies in peripheral blood after IX001 TCR-T injection infusion.
Measured: 2 years

Timeline

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

27 Mar 202527 Sep 2027

First posted27 Mar 2025
Study start27 Mar 2025
Primary completion27 Mar 2027 (estimated)
Study completion27 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: IX001 TCR-T injection
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06898385
Sponsor's protocol ID: IX001 TCR-T
Acronym: IX001 TCR-T
Status last verified: Jan 2026
First submitted: 21 Mar 2025
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Yuhong Li

87342487 ext. 020

liyh@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Pancreatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
ClinicalTrials.gov ID: NCT06898385
Acronym / sponsor ID: IX001 TCR-T / IX001 TCR-T
Conditions: Pancreatic Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 9 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: ImmuXell Biotech Ltd.
Study start: 27 Mar 2025 (actual)
Primary completion: 27 Mar 2027 (estimated)
Study completion: 27 Sep 2027 (estimated)
First posted: 27 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a single-arm, open-label clinical study to evaluate the safety, tolerability and preliminary efficacy of IX001 TCR-T injection in advanced pancreatic cancer patients with KRAS G12V mutation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: IX001 TCR-T injection

Arm	Type	Receives
IX001 TCR-T injection	Experimental	Biological: IX001 TCR-T injection, Drug: Fludarabine, Drug: CyclophosphamideIX001 TCR-T injection targeted for KRAS mutation

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Voluntary signing of an informed consent form (for Human Leukocyte Antigen (HLA) typing and tumor gene mutation test, and main screening)
2. Males or females, aged 18-75 years (inclusive)
3. Patients with pathologically (histopathologically) or cytologically confirmed pancreatic ductal adenocarcinoma
4. Patients with unresectable locally advanced or metastatic disease who fail standard of care, i.e., patients who have progression after prior gemcitabine-containing chemotherapy or FOLFIRINOX (oxaliplatin + irinotecan + calcium folinate + 5-FU) or NALIRIFOX (irinotecan liposome + oxaliplatin + calcium folinate + 5-FU) regimen, including those who have progression within 6 months after the end of neoadjuvant/adjuvant therapy
5. At least one measurable lesion (according to RECIST 1.1 criteria), specifically: longest diameter of ≥10 mm for non lymph node lesions or shortest diameter of ≥15 mm for lymph node lesions (tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable, unless unequivocal progression of the lesion is demonstrated by an evidence)

Key exclusion criteria (22 listed)

1. The subject is currently suffered from or have suffered from other incurable malignant tumors within previous 5 years, except in skin basal cell cancer、carcinoma in situ or breast cancer have received curative treatment with no recurrence within the past 3 years)
2. History of organ transplantation
3. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the Informed Consent Forms(ICF)
4. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs
5. Poorly controlled hypertension with drug (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IX001 TCR-T injectionIX001 TCR-T injection will be administered intravenously after lymphodepletion.	Biological	IX001 TCR-T injection
FludarabineAlso: FludaraFludarabine is used for lymphodepletion.	Drug	IX001 TCR-T injection
CyclophosphamideAlso: EndoxanCyclophosphamide is used for lymphodepletion.	Drug	IX001 TCR-T injection

Primary outcome

Dose-limiting Toxicity (DLT)
Time frame: 4 weeks
Proportion of patients with DLT
Adverse Events (AEs)
Time frame: 2 years
Incidence and severity of adverse events
Serious Adverse Events (SAEs)
Time frame: 2 years
Incidence and severity of serious adverse events

13 secondary outcomes

Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Changes in Serum Tumor Markers compared to Baseline
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
TCR gene copies
Time frame: 2 years
TCR-T cell counts
Time frame: 2 years
Pharmacodynamic of IX001 TCR-T injection
Time frame: 2 years
Changes in cytokine level
Time frame: 2 years
Changes in lymphocyte subpopulations
Time frame: 2 years
Proportion of patients with anti-IX001 antibodies
Time frame: 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Individual participant dataSharing planned: Undecided

Related trials for Pancreatic Cancer

RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yuhong Li contact

87342487 ext. 020

liyh@sysucc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IX001 TCR-T injection, Fludarabine and Cyclophosphamide in people with Pancreatic Cancer, run by Sun Yat-sen University 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 10 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 8 Jan 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yuhong Li (87342487 ext. 020, liyh@sysucc.org.cn), or a site near the patient. 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 NCT06898385.

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 8 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.