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Malignant Neoplasms of Digestive OrgansEarly Phase 1CARTNCT04652219

CART Therapy in GUCY2C-positive Digestive Tract Tumors

A Early Phase 1 study testing gucy2c cart cells in people with Malignant Neoplasms of Digestive Organs, run by Weijia Fang, MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Malignant Neoplasms of Digestive Organs
What is being tested?
gucy2c cart cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
10 Oct 2020to 9 Oct 2021
Phase
Early 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

  • 1. Aged between 18 and 70; 2. Positive expression of immunohistochemical (IHC) assay targets in a laboratory approved by the partner; 3. Pathology confirmed digestive tract tumor; 4. Patients who have failed or relapsed after at least the first and second line standard treatment, and patients who are intolerant to or voluntarily give up the standardized treatment; 5. At least one extracranial measurable lesion according to RECIST1.1 or EORTC or PERCIST; 6. Expected survival ≥90 days; 7. The main organs are functioning normally, i.e. they meet the following criteria:
  • ECOG physical condition score is 0~1 or KPS score is >70;
  • serum test criteria were as follows: HB≥90g/L (no blood transfusion within 14 days), ANC≥ 1.5 x 10^9/L, PLT≥80 x 10^9/L, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×ULN (upper limit of normal value).
  • Biochemical examination shall meet the following standards: TBIL≤ 1.5x ULN (upper limit of normal value); ALT and AST≤ 2.5x ULN; ALT and AST≤5xULN in case of liver metastasis; Serum Cr≤1xULN, endogenous creatinine clearance rate >50 ml/min (Cockcroft-Gault formula);
  • cardiac ejection fraction >55%; 8. No hemorrhagic disease or coagulation disorder; 9. No allergy to the developer; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use an appropriate method of contraception during and 8 weeks after the last dose of CART (women who have undergone sterilization or have been postmenopausal for at least 2 years may be considered sterile); 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Who cannot join

  • T cell transduction efficiency <5% or T cell amplification < 2 times after culture;
  • Participated in other drug clinical trials within 4 weeks before the start of the study;
  • Patients with hypertension and unable to obtain good control by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure b> 90 mmHg, the specific conditions shall be evaluated by the researchers) have myocardial ischemia or infarction of grade I or above, arrhythmia of grade I or above (including QT interval ≥ 440ms) or cardiac insufficiency;
  • A wound or fracture in the chest or other area that has not healed for a long time;
  • Has a history of substance abuse and is unable to quit or has a history of mental disorders;
  • Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.;
Show all 12Show fewer
  • Fungus, bacteria, virus or other infection that cannot be controlled or requires antibiotic treatment. The presence of a simple urinary tract infection and uncomplicated bacterial pharyngitis is permitted after consultation with a medical supervisor;
  • For subjects who have used chemotherapy before, according to NCI-CTCAE 4.0, there is grade ≥2 hematological toxicity or grade ≥3 non-hematological toxicity at the time of enrollment;
  • A known history of HIV, or a positive nucleic acid test for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive);
  • The presence of any indwered catheter or drainage tube (e.g., bile drainage tube or pleural/peritoneal/pericardial catheter). The use of specialized central venous catheters was permitted (the influence of fistula, percutaneous nephrostomy, and indwsed Foley catheters in colorectal cancer patients was considered by the investigators);
  • Brain metastases; A history or medical condition of CNS, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
  • 13. Significant immunodeficiency; 14. The major therapeutic drugs in this study (including fludalabine, cyclophosphamide, sodium meth, and tozumab and anti-infective drugs used to prevent and treat CRS) have a history of severe hypersensitivity reaction; 15. History of deep vein thrombosis or pulmonary embolism 6 months before enrollment; 16. A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in injury to the terminal organs or that requires systemic immunosuppressive/disease-modulating drugs in the past 2 years; 17. Any disease that may interfere with the evaluation of the safety or efficacy of the study treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital, Zhejiang University

    Hangzhou, Zhejiang, 310006

Other trials in China

About this study

Official title: Clinical Study on the Safety and Efficacy of CART Cells in the Treatment of Advanced GUCY2C-positive Digestive Tract Tumors

Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

Read the detailed description

The primary objective of phase 1 is to evaluate the safety of CART regimens. The primary objective of phase 2 is to evaluate the efficacy of CART, as measured by objective response rate in subjects with colorectal cancer. Secondary objectives will include assessing the safety and tolerability of CART and additional efficacy endpoints.

Being tested
gucy2c cart cells
Keywords
cart, gucy2c, Digestive tract tumor

What participants receive

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

  • gucy2c cart cellsBiological

    Patients with advanced malignant gastrointestinal tumors were injected with CART cells

Study groups in NCT04652219
Study groupRoleWhat they receive
Patients with late malignant digestive tract tumorExperimentalPatients with late malignant digestive tract tumor, for example metastatic colorectal cancer, pancreatic cancer, gastric cancer and so on. because of this is a open, single arm trail, there is no control group.
Receives: Biological: gucy2c cart cells

What is being measured

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

  1. Number of participants with CAR-T treatment-related adverse events as assessed by CTCAE v4.03

    The investigator is responsible for ensuring that all adverse events observed by the investigator or reported by the subject during the 3-month period from enrollment (i.e. initiation of leukocyte separation) to 3 months after targeted car-t infusion are monitored and reported. After three months, researchers will be required to monitor and report targeted adverse events, including neurological, blood, infection, autoimmune diseases, and secondary malignant tumors, for 24 months or until disease progression, whichever occurs first.

    Measured: 24 months

Secondary outcomes (2)

  1. The event of cytokine release syndrome was reported using the grading scale in the protocol.

    We will summarize the classification of cytokine release syndrome (CRS) according to the severity and system organ classification.

    Measured: 24 months

  2. Efficacy will be assessed according to RECIST1.1 or EORTC or PERCIST criteria.

    Remission will be evaluated by the central investigator at the time indicated in the evaluation plan. The disease was evaluated according to the response evaluation criteria in solid tumors RECIST version 1.1 or EORTC or percist. Flow cytometry, molecular or cytogenetic studies used in the trial will be used to assist, but will not be used alone to determine remission.

    Measured: 24 months

Timeline

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

  1. First posted3 Dec 2020
  2. Study start10 Oct 2020
  3. Primary completion9 Oct 2021
  4. Study completion9 Oct 2021

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652219
Sponsor's protocol ID
ICT-GC
Acronym
CART
Status last verified
Jul 2023
First submitted
9 Nov 2020
Last updated
17 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing gucy2c cart cells in people with Malignant Neoplasms of Digestive Organs, run by Weijia Fang, MD 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jul 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with CAR-T treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 24 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 NCT04652219.

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 17 Jul 2023.

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