Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Colorectal Cancer Advanced Gastric Cancer Advanced Hepatocellular Carcinoma Advanced Pancreatic Cancer

Keywords

EpCAMCAR-T

Outcome Measures

Primary Outcomes (3)

Dose limited toxicity （DLT）
Safety
28 days
Maximum Tolerated Dose（MTD）
Tolerability evaluation
28 days
Adverse Event(AE)
Incidence rate
28 days

Secondary Outcomes (8)

Study Arms (1)

EPCAM CAR-T

EXPERIMENTAL

The first stage: single dose escalation The classic "3+3" dose escalation test. The starting dose refers to the results of the previous test of subsequent subjects. In this study, 3 increasing dose levels were set up, with 3 to 6 cases per dose. * The first dose group is 3×10\^5/kg, allowing 10% dose error. * The second dose group is 1×10\^6/kg, allowing 10% dose error. * The third dose group is 3×10\^6/kg, allowing 10% dose error. Each dose group must complete the DLT observation before entering the next dose group; when the first subject in the same dose group has no DLT observed for at least 14 days after cell infusion, the subsequent subjects can receive cell infusion. The second stage: combined radiofrequency/microwave ablation for the treatment of advanced digestive system malignant tumors with liver metastases

Drug: EPCAM CAR-T

Interventions

EPCAM CAR-TDrug

Pretreatment with fludarabine and cyclophosphamide EpCAM CAR-T Cells infusion

EPCAM CAR-T

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 and 70 years old (including boundary value), both male and female.
The first stage requires patients with malignant tumors of the digestive system (including advanced gastric cancer, advanced colorectal cancer, advanced pancreatic cancer, advanced liver cancer) who have failed previous standard treatments and have no other feasible effective treatment methods. The documents for the diagnosis of advanced digestive system malignancies include imaging reports (CT/MRI) or pathological examination results. The second stage requires patients with liver metastases of advanced digestive system malignancies (including gastric cancer liver metastasis, colorectal cancer liver metastasis, and pancreatic cancer liver metastasis) who have previously failed standard treatment and have no other feasible effective treatment methods. The investigator can judge it. Perform radiofrequency/microwave ablation therapy. Documents for diagnosing liver metastases from advanced digestive system malignancies include imaging reports (CT/MRI) or pathological examination results.

Sponsors & Collaborators

Zhejiang University
Otherlead

Study Sites (2)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

Yongle XieCONTACT86-13585921958/862168383131

Yimin Mao, DrPRINCIPAL INVESTIGATOR

Bo Zhai, DrPRINCIPAL INVESTIGATOR

First affiliated hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

Weijia Fang, DoctorCONTACT

Study Officials

Weijia Fang
First Affiliated Hospital of Zhejiang University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Bowen Peng

CONTACT

+86 18870300543 bowen.peng@immunofoco.com

Saixue Zhang

CONTACT

+86 19857143032/8657187237646

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: professor

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 31, 2021

Study Start

September 30, 2021

Actual (reported)

You may not qualify if:

Subjects who meet any of the following conditions cannot be selected for this study;
Women during pregnancy and lactation.
Known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive); acute or chronic active hepatitis C (HCV antibody positive). Syphilis antibody is positive; Epstein-Barr virus DNA quantitative\> 500 copies; Cytomegalovirus (CMV) infection (IgM positive).
Severe infections that are active or poorly clinically controlled.
At present, there is a heart disease requiring treatment or a poorly controlled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure \>90 mmHg after treatment with standardized antihypertensive drugs).
The presence of any of the following cardiac clinical symptoms or diseases:
Unstable angina;
Myocardial infarction occurred within 1 year;
ECG at rest QTc\>450ms (male) or QTc\>470ms (female);
The resting state ECG examination found abnormalities of important clinical significance (such as abnormal heart rate, conduction, morphological characteristics, etc.) or complete left bundle branch block or third-degree heart block or second-degree heart block or PR Interval\> 250ms;
There are factors that increase the risk of QTc prolongation and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or sudden death of unexplained family members under 40 years old, or prolonged periods Period concomitant medication.
Abnormal blood coagulation function (INR\>1.5×ULN), bleeding tendency or receiving thrombolysis or conventional anticoagulation therapy (such as warfarin or heparin), patients need long-term antiplatelet therapy (aspirin, dose\> 300mg/day; Clopidogrel, dose\>75mg/day).
Subjects who need to use corticosteroids or other immunosuppressive drugs for systemic therapy during the treatment period.
Before treatment, blood oxygen saturation ≤95% (referring to pulse oxygen detection).
Have received systemic steroids equivalent to \>15 mg/day of prednisone within 2 weeks before apheresis, except for inhaled steroids.
+13 more criteria

IMC001 for Clinical Research on Advanced Digestive System Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (8)

Study Arms (1)

EPCAM CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (8)

Study Arms (1)

EPCAM CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations