A Study to Evaluate the Safety and Efficacy of ly011 Cell Injection in the Treatment of Advanced Gastric Adenocarcinoma

NCT04977193 | Unknown Early Phase 1

• 1 other identifier: LY011C1002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Objective to evaluate the safety and efficacy of ly011 cell injection in the treatment of advanced gastric adenocarcinoma.

Conditions

Advanced Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerable dose（MTD）

  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]

  AEs according to CTCAE v 5.0.

  2 years

Secondary Outcomes (9)

• Overall Response rate（ORR）

  2 years

• Area under the curve from time 0 to the last time point (AUC0-t)

  1 years

• Apparent clearance (CL)

  1 years

• Maximum concentration (Cmax)

  1 years

• Half-life (T½）

  1 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Biological: LY011

Interventions

LY011 BIOLOGICAL

CAR-T

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Longyao Biotechnology Inc., Ltd.: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 26, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2024
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

CN (1)