TCR-T Cells in the Treatment of Advanced Pancreatic Cancer

NCT ID: NCT06054984

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2024-09-07

Brief Summary

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

Detailed Description

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

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 cancer who lack effective treatment methods, so that the benefits of patients participating in clinical trials will outweigh the risks.

Group Type: EXPERIMENTAL

TCR-T Cells Injection（GB3010 Cells Injection）

Intervention Type: DRUG

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 escalation groups(dose level 1-3) :5×10\^8±20%,5×10\^9±20%,5×10\^10±20%.

Interventions

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 escalation groups(dose level 1-3) :5×10\^8±20%,5×10\^9±20%,5×10\^10±20%.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Essight Bio Co.,Ltd

UNKNOWN

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BoYongShen

Role: STUDY_DIRECTOR

Ruijin Hospital

Locations

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

ChenLeiWen

Role: CONTACT

wcl12161@rjh.com.cn

13761638756

BoYongShen

Role: CONTACT

shenby@shsmu.edu.cn

13901943778

Facility Contacts

ChenLeiWen

Role: primary

wcl12161@rjh.com.cn

13761638756

BoYongShen

Role: backup

shenby@shsmu.edu.cn

13901943778

Other Identifiers

(2021) IEC No.288

Identifier Type: -

Identifier Source: org_study_id