AzTrials
AzTrials

Pancreatic CancerEarly Phase 1NCT06828328

A Study of GC203 TIL in PDCA (RJ)

A Early Phase 1 study testing GC203 TIL in people with Pancreatic Cancer and Pancratic Ductal Adenocarcinoma, run by Shanghai Juncell Therapeutics 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
Search all trials

Trial summary

This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. Gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
GC203 TIL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
10 Feb 2025to 31 Jan 2028
Phase
Early 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have done the tumor resection for gene-edited GC203 TIL production and successfully produced；
  • Age: 18 years to 70 years;
  • Histologically diagnosed as pancreatic ductal adenocarcinoma;
  • Expected life-span more than 3 months;
  • ECOG score 0-1;
  • Test subjects have failed standard treatment regimens, and be willing to recieve gene-edited GC203 TIL therapy;
Show all 9Show fewer
  • At least 1 evaluable tumor lesion;
  • Hematology and Chemistry（within 7 days prior to enrollment）:
  • Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×109/L； Platelet count≥90×10^9； hemoglobin≥90 g/L; Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN; 9.Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion； 10.Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs; 12.Be able to understand and sign the informed consent document; 13.Be able to stick to follow-up visit plan and other requirements in the agreement.

Who cannot join

  • with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  • Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
  • Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is < 95%;
  • Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
  • Significant cardiovascular anomalies according to any of the following definition:
  • New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
Show all 21Show fewer
  • Uncontrolled metabolic disorders, such as diabetes, which is known to be uncontrolled, or other non-malignant organ or systemic disease or cancer secondary reactions, can lead to higher medical risk and/or uncertainty in the evaluation of survival;
  • Patients with esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or who, in the opinion of the investigator or in consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegalgia on imaging) or a history of varicose bleeding must undergo endoscopic evaluation within the first 3 months of enrollment;
  • Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis, liver failure;
  • Pulmonary fibrosis, interstitial lung disease (both past and present), acute lung disease;
  • Clinically uncontrollable third space effusion, such as pleural fluid and ascites that could not be controlled by drainage or other means prior to enrollment;
  • Patients with known pnelmeningeal metastases; Other patients known to have uncontrolled or untreated central nervous system metastases that are not effectively controlled by treatment, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to cell retransfusion;
  • Severe physical or mental diseases;
  • Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
  • Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
  • History of allogeneic T cell therapy;
  • Having received immunotherapy and developed irAE level greater than Level 3;
  • Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
  • Females in pregnancy or lactation;
  • History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
  • Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Trial locations and contacts

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

boyong shen contact

086-18001759113

clinicaltrials@juncell.com

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality

    Ruijin Hospital Ethics Committee, 0086-021-64370045, eso_zsy@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Pancreatic Ductal Adenocarcinoma

This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. Gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Being tested
GC203 TIL
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GC203 TILBiological

    the candidates will be assigned to GC203 TIL(gene-edited TIL) group

Study groups in NCT06828328
Study groupRoleWhat they receive
GC203 TILExperimental5x10^8-1.5x10^10 ±20% in vitro expanded GC203 TILs will be infused i.v. to patients with pancreatic ductal adenocarcinoma after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Receives: Biological: GC203 TIL

What is being measured

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

  1. Adverse Events

    To characterize the safety profile of GC203 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events.

    Measured: 6 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: Up to 36 months

  2. Disease Control Rate (DCR）

    Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1

    Measured: Up to 36 months

  3. Duration of Response (DOR)

    The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

    Measured: Up to 36 months

  4. Progression-Free Survival (PFS)

    The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

    Measured: Up to 36 months

  5. Overall Survival(OS)

    The time length between TIL infusion and death

    Measured: Up to 36 months

Timeline

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

  1. First posted14 Feb 2025
  2. Study start10 Feb 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828328
Sponsor's protocol ID
GC203-2024-RJ-PDCA
Status last verified
Aug 2026
First submitted
10 Feb 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GC203 TIL in people with Pancreatic Cancer and Pancratic Ductal Adenocarcinoma, run by Shanghai Juncell Therapeutics 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 9 inclusion and 21 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 5 Aug 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 boyong shen (086-18001759113, clinicaltrials@juncell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 6 months). 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 NCT06828328.

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 5 Aug 2026.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in