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Clinical Trial Record

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TCR-T Cells in the Treatment of Advanced Pancreatic Cancer

2021-09-07

2024-06-07

2024-09-07

18

Study Overview

TCR-T Cells in the Treatment of Advanced Pancreatic Cancer

To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer

The aim of this clinical trial is to investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cell therapy in patients with advanced pancreatic cancer by intravenous injection, in order to explore an effective cellular immunotherapy method for the treatment of advanced pancreatic cancer

  • Pancreatic Cancer
  • DRUG: TCR-T Cells Injection（GB3010 Cells Injection）
  • (2021) IEC No.288

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 Registration Dates Results Reporting Dates Study Record Updates

2023-03-31  

N/A  

2023-10-11  

2023-09-19  

N/A  

2023-10-13  

2023-09-26  

N/A  

2023-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: TCR-T Cells Injection（GB3010 Cells Injection）

This study was designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of TCRT cell injection (GB3010) in patients with advanced pancreatic cancer by intravenous injection. The target population is patients with advanced pancreatic c

DRUG: TCR-T Cells Injection（GB3010 Cells Injection）

  • The TCRT cells used in this clinical trial were derived from the patient's autologous peripheral-blood T cells and were genetically transduced to express a T-cell Receptor that recognizes the RAS/TP53.Patients were sequentially enrolled into 3 dose e
Primary Outcome MeasuresMeasure DescriptionTime Frame
Evaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancercollect adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and laboratory abnormalities (type, frequency, and severity)2years
Characterize the Peak of Peripheral Blood Concentration and Area under the Peripheral Blood concentration versus time curve of TCRT cells and observe their proliferation and persistence in bodyAfter infusion of neoantigen-specific TCRT cells, collect peak (Cmax) of neoantigen-specific TCRT cells in blood and tumor tissue, time to peak (number of days to peakTCRT cells after infusion), Tmax) and AUC0-28 (area under the curve plotted against visit time by the number of neoantigen-specific TCRT cells in peripheral blood from day 0 to 28). "If possible, AUC0-inf, terminal phase elimination rate constant (λz), elimination half-life (t1/2) will be evaluated."2years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Correlation of the pharmacokinetic profile of TCRT cells with the Incidence of CRS and ICANS eventscollect changes in mutant cell concentration in peripheral blood and tumor tissue after TCRT cell reinfusion,observe correlation of these measures with CRS and ICANS events2years
Evaluate tumor size (mm) , tumor biomarker CA19-9 (U/ml), ORR/DCR/PFS and OS of patients with advanced pancreatic cancerORR at 2, 4, and 6 months after TCRT cell infusion (ORR=CR+PR). The primary efficacy outcome was the change in target tumor size (local control rate of target lesions). Secondary efficacy indicators: changes in tumor markers; Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) according to RECIST1.1 criteria2years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ChenLeiWen

Phone Number: 13761638756

Email: wcl12161@rjh.com.cn

Study Contact Backup

Name: BoYongShen

Phone Number: 13901943778

Email: shenby@shsmu.edu.cn

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • To be eligible for the study, patients must meet all of the following criteria:

    • 1. Male or female, aged 18-75 years; 2. Patients with advanced pancreatic cancer diagnosed by histology or cytology, patients who failed to respond to standard treatment, relapsed or voluntarily gave up; 3. Patients must have tumor tissue that expresses specific tumor antigens, such as mutations in RAS and/or TP53; 4. Patients must undergo HLA matching testing and meet the requirements of HLA matching. 5. At least one measurable or evaluable lesion ≥15 mm according to RECIST1.1 criteria; 6. Patients with ECOG < 2 and life expectancy ≥3 months; 7. a) Liver function: ALT/AST < 3 times the upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L; b) renal function: creatinine < 220μmol/L; c) terminal oxygen saturation ≥95% in room air; d) Cardiac function: left ventricular ejection fraction (LVEF) ≥60%; e) Blood routine: absolute neutrophil count ≥ 1×109/L; Platelet count ≥70×109/L; Absolute lymphocyte count ≥100 cells /μL; 8. The patients met the requirements of apheresis without any contraindications. 9. Women of childbearing age who have a negative urine pregnancy test at screening and before starting dosing and who have agreed to use highly effective contraception for at least 100 days after infusion; Female participants must agree not to donate eggs (oocytes, oocytes) for assisted reproductive purposes during the study and for 90 days after receiving the last study drug; 10. Male subjects with a fertile partner must consent to use an effective barrier method of contraception for at least 100 days after infusion; Must agree not to donate sperm for at least one year; 11. Sign an informed consent form.
    Exclusion Criteria:

  • Patients who met any of the following criteria were not eligible for inclusion in the study:

    • 1. Persons with severe mental disorders; 2. A positive virological test for any of the following: HIV; HCV; HBsAg; HBcAb was positive, and HBV DNA copy number and TPPA were positive. 3. Patients with severe allergic history or allergic constitution; 4. Severe underlying medical conditions such as evidence of other serious active viral, bacterial or uncontrolled systemic fungal infection; Active autoimmune disease or a history of autoimmune disease within 3 years; 5. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; 6. Combined with organ dysfunction, such as renal insufficiency; 7. Had been enrolled in another clinical trial within 4 weeks before enrollment in the trial; 8. Those who were unable to comply with the study protocol and follow-up plan due to physiological, family, social, geographical and other factors; 9. Patients with contraindications to cyclophosphamide or fludarabine chemotherapy; 10. Subjects who required additional immunosuppressive drug therapy within 72 hours before TCR-T infusion, except for the treatment of adverse events during the trial; 11. Pregnant, lactating women, or men who plan to have children while participating in the study or within 100 days of receiving study treatment; 12. Any other condition considered by the investigator to be ineligible for enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Shanghai Essight Bio Co.,Ltd
  • STUDY_DIRECTOR: BoYongShen, Ruijin Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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