Gastric CancerEarly Phase 1NCT05447234
TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
A Early Phase 1 study testing Tcrx T cell in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Tcrx T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old;
- Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
- Expected survival time ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
- Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕)
- Normal liver and kidney function: serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) <2.5UNL, alkaline phosphatase <5UNL; serum creatinine <1.5mg/dl;
- Men and women must take appropriate contraceptive measures.
Who cannot join
- Patients with previous non-gastric/gastroesophageal junction malignant tumor
- History of severe acute allergy
- There is an uncontrolled infection
- History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
- History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
- History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure
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- Poor control of hypertension
- QT interval >480ms
- Evidence of active bleeding or bleeding tendency
- Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation
- Grade 3 or 4 diarrhea
- Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures
- Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration
- Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish
- Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia
- Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study
- Pregnant or lactating women
- Men or women planning to become pregnant within the next six months
About this study
Official title: Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.
Read the detailed description
- Sign the informed consent for clinical trials
- Subject screening
- Extract the blood of the subjects and isolate the PBMC
- Find a patient-specific tumor-specific TCR sequence combination, which is a multi-targeted tumor-specific combination.
- Transfer of personalized tumor-specific TCRs into patient autologous CD8 T cells by gene editing
- Large-scale culture and expansion of gene-edited T cells
- T cell viability, infection efficiency and microbial detection in hospital
- Calculate the number of cells in the patient's body according to TCRx T
- Injecting TCRx T cells back into the subject
- Within 7 days after the injection, the subject's post-dose reaction should be closely observed in the hospital
- After the first injection, continue to reinfuse TCRx T cells up to 4 times according to the treatment effect and the incidence of adverse events, and be hospitalized after each injection to closely monitor possible adverse events
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Being tested
- Tcrx T cell
- Keywords
- T Cell Receptor, Gastric Cancer, Gastroesophageal-junction Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tcrx T cellBiological
Sequential IV infusion
| Study group | Role | What they receive |
|---|---|---|
| TCRX-T | Experimental | ① 1x10^7/m2 ;
* 3x10^7/m2；
* 1x10^8/m2；
* 3x10^8/m2；
* 1x10^9/m2。 Receives: Biological: Tcrx T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor volume
RECIST 1.1
Measured: about 2 years
Overall Survival
The time from randomization to death due to any reason.
Measured: about 2 years
Secondary outcomes (1)
AEs
CTCAE5.0
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- ① 1x10\^7/m2 * 3x10\^7/m2； * 1x10\^8/m2； * 3x10\^8/m2； * 1x10\^9/m2。
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TCRx Therapeutics Co.Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447234
- Sponsor's protocol ID
- KSH02-TCRXT-CJ
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
- ClinicalTrials.gov ID
- NCT05447234
- Acronym / sponsor ID
- KSH02-TCRXT-CJ
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Keywords
- T Cell Receptor, Gastric Cancer, Gastroesophageal-junction Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- TCRx Therapeutics Co.Ltd
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Jul 2022 (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 observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.
Detailed description
- Sign the informed consent for clinical trials
- Subject screening
- Extract the blood of the subjects and isolate the PBMC
- Find a patient-specific tumor-specific TCR sequence combination, which is a multi-targeted tumor-specific combination.
- Transfer of personalized tumor-specific TCRs into patient autologous CD8 T cells by gene editing
- Large-scale culture and expansion of gene-edited T cells
- T cell viability, infection efficiency and microbial detection in hospital
- Calculate the number of cells in the patient's body according to TCRx T
- Injecting TCRx T cells back into the subject
- Within 7 days after the injection, the subject's post-dose reaction should be closely observed in the hospital
- After the first injection, continue to reinfuse TCRx T cells up to 4 times according to the treatment effect and the incidence of adverse events, and be hospitalized after each injection to closely monitor possible adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ① 1x10^7/m2 * 3x10^7/m2； * 1x10^8/m2； * 3x10^8/m2； * 1x10^9/m2。
| Arm | Type | Receives |
|---|---|---|
| TCRX-T | Experimental | Biological: Tcrx T cell① 1x10^7/m2 ; * 3x10^7/m2； * 1x10^8/m2； * 3x10^8/m2； * 1x10^9/m2。 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-70 years old;
- Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
- Expected survival time ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
Key exclusion criteria (18 listed)
- Patients with previous non-gastric/gastroesophageal junction malignant tumor
- History of severe acute allergy
- There is an uncontrolled infection
- History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
- History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
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 |
|---|---|---|
| Tcrx T cellSequential IV infusion | Biological | TCRX-T |
Primary outcome
tumor volume
Time frame: about 2 years
RECIST 1.1
Overall Survival
Time frame: about 2 years
The time from randomization to death due to any reason.
1 secondary outcome
AEs
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tcrx T cell in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 inclusion and 18 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: opening soon, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor volume (time frame: about 2 years). 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 16 Feb 2023.