Pancreatic CancerEarly Phase 1GB3010-02NCT06054984
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
A Early Phase 1 study testing TCR-T Cells Injection（GB3010 Cells Injection） in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- TCR-T Cells Injection（GB3010 Cells Injection）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2021to 7 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, patients must meet all of the following criteria:
- Male or female, aged 18-75 years;
- Patients with advanced pancreatic cancer diagnosed by histology or cytology, patients who failed to respond to standard treatment, relapsed or voluntarily gave up;
- Patients must have tumor tissue that expresses specific tumor antigens, such as mutations in RAS and/or TP53;
- Patients must undergo HLA matching testing and meet the requirements of HLA matching.
- At least one measurable or evaluable lesion ≥15 mm according to RECIST1.1 criteria;
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- Patients with ECOG < 2 and life expectancy ≥3 months;
- 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;
- The patients met the requirements of apheresis without any contraindications.
- 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;
- 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;
- Sign an informed consent form.
Who cannot join
- Patients who met any of the following criteria were not eligible for inclusion in the study:
- Persons with severe mental disorders;
- A positive virological test for any of the following: HIV; HCV; HBsAg; HBcAb was positive, and HBV DNA copy number and TPPA were positive.
- Patients with severe allergic history or allergic constitution;
- 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;
- 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;
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- Combined with organ dysfunction, such as renal insufficiency;
- Had been enrolled in another clinical trial within 4 weeks before enrollment in the trial;
- Those who were unable to comply with the study protocol and follow-up plan due to physiological, family, social, geographical and other factors;
- Patients with contraindications to cyclophosphamide or fludarabine chemotherapy;
- Subjects who required additional immunosuppressive drug therapy within 72 hours before TCR-T infusion, except for the treatment of adverse events during the trial;
- Pregnant, lactating women, or men who plan to have children while participating in the study or within 100 days of receiving study treatment;
- Any other condition considered by the investigator to be ineligible for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
ChenLeiWen, 13761638756, wcl12161@rjh.com.cn
BoYongShen, 13901943778, shenby@shsmu.edu.cn
About this study
Official title: To Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of T Cell Receptor T Cell Therapy 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
Read the 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
- Being tested
- TCR-T Cells Injection（GB3010 Cells Injection）
- Keywords
- TCR-T, T cells, RAS, TP53, Cell therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-T Cells Injection（GB3010 Cells Injection）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%.
| Study group | Role | What they receive |
|---|---|---|
| TCR-T Cells Injection（GB3010 Cells Injection） | Experimental | 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. Receives: Drug: TCR-T Cells Injection（GB3010 Cells Injection） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancer
collect adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and laboratory abnormalities (type, frequency, and severity)
Measured: 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 body
After 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."
Measured: 2years
Secondary outcomes (2)
Correlation of the pharmacokinetic profile of TCRT cells with the Incidence of CRS and ICANS events
collect changes in mutant cell concentration in peripheral blood and tumor tissue after TCRT cell reinfusion,observe correlation of these measures with CRS and ICANS events
Measured: 2years
Evaluate tumor size (mm) , tumor biomarker CA19-9 (U/ml), ORR/DCR/PFS and OS of patients with advanced pancreatic cancer
ORR 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 criteria
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Sep 2021
- Primary completion7 Jun 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients were sequentially enrolled into 3 dose escalation groups(dose level 1 to 3):5×10\^8±20%,5×10\^9±20%,5×10\^10±20%. Twenty-eight days after infusion of GB3010 cells was the observation period for DLT evaluation.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Essight Bio Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- BoYongShen, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054984
- Sponsor's protocol ID
- (2021) IEC No.288
- Acronym
- GB3010-02
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of T Cell Receptor T Cell Therapy in the Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06054984
- Acronym / sponsor ID
- GB3010-02 / (2021) IEC No.288
- Conditions
- Pancreatic Cancer
- Keywords
- TCR-T, T cells, RAS, TP53, Cell therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Essight Bio Co.,Ltd
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were sequentially enrolled into 3 dose escalation groups(dose level 1 to 3):5×10^8±20%,5×10^9±20%,5×10^10±20%. Twenty-eight days after infusion of GB3010 cells was the observation period for DLT evaluation.
| Arm | Type | Receives |
|---|---|---|
| TCR-T Cells Injection（GB3010 Cells Injection） | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible for the study, patients must meet all of the following criteria:
Key exclusion criteria (13 listed)
- Patients who met any of the following criteria were not eligible for inclusion in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%. | Drug | TCR-T Cells Injection（GB3010 Cells Injection） |
Primary outcome
Evaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancer
Time frame: 2years
collect adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and laboratory abnormalities (type, frequency, and severity)
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 body
Time frame: 2years
After 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."
2 secondary outcomes
Correlation of the pharmacokinetic profile of TCRT cells with the Incidence of CRS and ICANS events
Time frame: 2years
Evaluate tumor size (mm) , tumor biomarker CA19-9 (U/ml), ORR/DCR/PFS and OS of patients with advanced pancreatic cancer
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BoYongShen study director
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TCR-T Cells Injection（GB3010 Cells Injection） in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChenLeiWen (13761638756, wcl12161@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancer (time frame: 2years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.