- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977193
A Study to Evaluate the Safety and Efficacy of ly011 Cell Injection in the Treatment of Advanced Gastric Adenocarcinoma
July 23, 2021 updated by: Shanghai Longyao Biotechnology Inc., Ltd.
to Evaluate the Safety and Efficacy of LY011 Cell Injection(Targeting CLDN 18.2 Chimeric Antigen Receptor T Cells) in the Treatment of Advanced Gastric Adenocarcinoma
Objective to evaluate the safety and efficacy of ly011 cell injection in the treatment of advanced gastric adenocarcinoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221000
- Recruiting
- The Affiliated Hospital of Xuzhou Medical University
-
Contact:
- Jun Song, Chief physician
- Phone Number: 0516-85609999
- Email: xyfyll2297@163.com
-
Principal Investigator:
- June Song
-
Sub-Investigator:
- Li Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be enrolled in this study:
- They were 18 to 70 years old, male or female; Histologically confirmed recurrent or metastatic advanced gastric adenocarcinoma (including gastric adenocarcinoma at the gastroesophageal junction);
- Claudin 18.2 IHC staining was positive in tumor tissues;
- Patients with advanced gastric adenocarcinoma who are not cured by second-line chemotherapy and unwilling to accept second-line chemotherapy after failure of first-line chemotherapy;
- Life expectancy > 12 weeks;
- According to RECIST 1.1, there was at least one measurable tumor target (≥ 10 mm);
- ECoG scores at screening, 24 hours before puncture and baseline (before treatment) were 0-1;
- Adequate organ function;
- For women of childbearing age with negative pregnancy test or male subjects, effective and reliable contraceptive methods must be adopted until 30 days after the end of treatment;
- Have enough understanding ability to voluntarily sign informed consent to participate in clinical research.
Exclusion Criteria:
Subjects who met any of the following criteria were not included in this study:
The patients received the following anti-tumor treatment before transplantation:
- Cytotoxic treatment within 14 days
- Small molecule targeted therapy for 14 days or at least 5 half lives, whichever is longer
- Experimental drug treatment within 28 days (if the above treatment is also experimental drug treatment, the 28 day flushing period should be followed)
- The patients were treated with monoclonal antibody within 28 days
- Immunomodulatory therapy within 7 days
- Radiotherapy within 14 days
- Pregnant or lactating women;
- Serological positive for HIV, Treponema pallidum or HCV;
- Any uncontrollable active infection, including but not limited to active tuberculosis and HBV infection (HBsAg positive, HBcAb positive and HBV DNA positive);
- The subjects were judged as clinically significant thyroid dysfunction by the investigators (serum thyroid hormone determination TT4, TT3, FT3, FT4, serum thyroid stimulating hormone TSH) and were not suitable to participate in this study;
- The side effects caused by previous treatment did not recover to CTCAE ≤ 1;
- Subjects who are currently using steroids throughout the body within 7 days before de pregnancy; Recent or recent use of inhaled steroids was not excluded;
- Any previous treatment for claudin 18.2;
- Previous allergy to immunotherapy and related drugs, severe allergy or allergic history;
- T cells (including car-t and tcr-t) that have been modified by chimeric antigen receptor;
- The subjects had untreated or symptomatic brain metastases;
- The subjects had central or extensive lung metastases;
- The subjects had heart disease requiring treatment or lost control of hypertension after treatment (blood pressure > 160 mmHg / 100 mmHg);
- Subjects with a history of organ transplantation or waiting for organ transplantation;
- There is no other serious disease that may restrict the subjects to participate in this trial;
- The researcher assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol;
- Blood oxygen saturation ≤ 95% before treatment (receiving finger oxygen test);
- Before pretreatment, subjects developed new arrhythmias, including but not limited to arrhythmias that could not be controlled by drugs, hypotension requiring vasopressin, bacterial, fungal or viral infections requiring intravenous antibiotics; The creatinine clearance rate was less than 40 ml / min; Investigators concluded that the subject was not suitable for further study. Subjects who use antibiotics to prevent infection can continue the trial if the researcher makes a judgment;
- There are signs of central nervous system diseases or abnormal results of nervous system tests, which are of clinical significance;
- The subjects were suffering from or had other malignant tumors that could not be cured within 3 years, except for cervical cancer in situ or basal cell carcinoma of skin;
- known hypersensitivity to excipients and related adjuvants (including but not limited to dimethyl sulfoxide and dextran-40) of the study drug;
- other conditions considered unsuitable by the researchers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
CAR-T
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerable dose(MTD)
Time Frame: 1month
|
MTD determination will based on the incidence of reported adverse events (including dose-limiting toxicities) and abnormal laboratory test results.
|
1month
|
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: 2 years
|
AEs according to CTCAE v 5.0.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response rate(ORR)
Time Frame: 2 years
|
the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
|
2 years
|
Area under the curve from time 0 to the last time point (AUC0-t)
Time Frame: 1 years
|
Area under the curve from time 0 to the last time point for serum CAR-T cells
|
1 years
|
Apparent clearance (CL)
Time Frame: 1 years
|
Apparent clearance for serum CAR-T cells
|
1 years
|
Maximum concentration (Cmax)
Time Frame: 1 years
|
Maximum concentration for serum CAR-T cells
|
1 years
|
Half-life (T½)
Time Frame: 1 years
|
Half-life for serum CAR-T cells
|
1 years
|
Area under the serum concentration-time curve (AUC0-inf)
Time Frame: 1 years
|
Area under the serum concentration-time curve for serum CAR-T cells
|
1 years
|
Time to maximum concentration (Tmax)
Time Frame: 1 years
|
Time to maximum concentration for serum CAR-T cells
|
1 years
|
Terminal elimination rate constant (λz)
Time Frame: 1 years
|
Terminal elimination rate constant for serum CAR-T cells
|
1 years
|
Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]
Time Frame: 1 years
|
Area under the curve above baseline of ANC for serum CAR-T cells
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
July 12, 2021
First Submitted That Met QC Criteria
July 23, 2021
First Posted (Actual)
July 26, 2021
Study Record Updates
Last Update Posted (Actual)
July 26, 2021
Last Update Submitted That Met QC Criteria
July 23, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LY011C1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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