Advanced Tumor of Digestive Tract or Urinary SystemPhase 1NCT05499715
A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy of ScTIL Injection (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Advanced Malignant Solid Tumors
A Phase 1 study testing ScTIL injection in people with Advanced Tumor of Digestive Tract or Urinary System, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is an open-lable, single-arm, dose escalation and dose extension phase I clinical study of ScTIL designed to observe and evaluate the safety, the tolerance, the pharmacokinetic characteristics and the effectiveness of ScTIL in the treatment of advanced malignant solid tumors, in order to provide the basis for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumor of Digestive Tract or Urinary System
- What is being tested?
- ScTIL injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Aug 2024
- Phase
- 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
- Age ≥ 18 and ≤ 75, regardless of gender;
- Eastern United States Cancer Collaborative Group (ECOG) physical condition score is 0 to1;
- Anticipated survival > 3 months;
- Advanced digestive tract tumor or urinary system tumor confirmed by histology or cytology;
- Patients with unresectable locally advanced or metastatic malignant digestive or urinary system tumors who have failed at least the first-line standard treatment;
- According to iRECIST standard, at least one tumor lesion can be measured by CT or MRI. Measurable tumor lesions are defined as the longest diameter ≥ 10mm and the scanning thickness does not exceed 5.0mm. For lymph node lesions, the short diameter ≥ 15mm;
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- PD-1 positive T cells in peripheral blood accounts for≥ 18% of total T lymphocytes (By detection standard of BD accuri C6 flow cytometer);
- Voluntarily accept the use of peripheral blood cell apheresis to obtain cells for the preparation of ScTIL cells;
- Sufficient bone marrow and organ functions:
- Hematology: neutrophils is equal to or higher than 1.5×10^9/L, platelets is equal to or higher than 75×10^9/L, hemoglobin is equal to or higher than 90g/L; total lymphocytes is equal to or higher than 60% of the lower limit of normal range;
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both eqal to or lower than 2.5 times the upper limit of normal range (ULN) (if intrahepatic metastatic tumor exists, equal to lower than 5 times of ULN); total bilirubin (TBIL) is equal to or lower than 1.5 times of ULN;
- Kidney function: Creatinine (Cr) is equal to or lower than 1.5 times of ULN, or creatinine clearance is equal or higher than 60;
- Coagulation function: Activated partial prothrombin time (APTT) is equal to or shorter than1.5 times of ULN; international normalized ration (INR) is equal to or shorter than1.5 times of ULN;
- Qualified patients with fertility (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence, etc.) with their partners during the trial and at least 90 days after the last medication; The blood or urine pregnancy test within 7 days before the first use of the study drug in women of childbearing age (see Appendix 8 for the definition) must be negative;
- Study subjects must obtain informed consent to this study and voluntarily sign a written informed consent before screening for enrollment..
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, so it is not suitable to be included in the study according to the judgment of the researcher;
- Patients who had in recent 5 years or currently have other malignant tunors, except for cured basal cell skin cancer, in situ cervical carcinoma, and in situ lung cancer, before signing the ICF;
- Patients who received PD-L1 monoclonal antibody treatment within 12 weeks before apheresis (including but not limited to atilizumab and dovalizumab);
- There was active infection within 1 week before apheresis, and systemic anti-infection treatment was currently required;
- Currently suffering from interstitial lung disease;
- Had received immunotherapy and had ≥ grade 3 IrAE;
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- Patients with active or had autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); Except for patients with clinically stable autoimmune thyroid disease and well-controlled type I diabetes;
- The adverse reaction of previous anti-tumor treatment has not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except for the toxicity without safety risk judged by researchers such as hair loss);
- Received anti-tumor treatment within 2 weeks before apheresis, including but not limited to chemotherapy, radiotherapy, immunotherapy, traditional Chinese medicine with anti-tumor indications, etc., except for the following:
- Nitrosourea or mitomycin C within 6 weeks before harvest;
- Oral fluorouracils and small molecule targeted drugs were taken 1 week before apheresis.
- Received systemic glucocorticoid (prednisone >10mg/day or equivalent dose of similar drugs) or other immunosuppressant treatment within 2 weeks before apheresis; Except for the following cases: Intermittent use of local, eye, intra-articular, intranasal and inhaled glucocorticoids; Short term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);
- Within 4 weeks before apheresis:
- Have received other unlisted clinical research drugs or treatments;
- Having undergone major organ surgery (excluding puncture biopsy) or significant trauma, or requires scheduled hospitalization during the trial period;
- Used live attenuated vaccine;
- Hepatitis B: HBsAg (+) or HBeAg (+); Or anti HBe (+)/anti HBc (+) and the DNA quantity of hepatitis B is higher than the detection limit of the research center; Hepatitis C: anti HCV positive; Treponema pallidum antibody (+);
- Have a history of immunodeficiency, including HIV antibody test positive;
- Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular blockade, etc;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events ≥ grade 3 occurred within 6 months before the cell reinfusion;
- New York Heart Association (NYHA) cardiac function rating ≥ class II or left ventricular ejection fraction (LVEF) < 50%, or structural heart disease with high risk judged by other researchers;
- Clinically uncontrollable hypertension;
- Serous cavity effusion beyond clinical control as judged unsuitable for being enrolled by the researcher;
- Known alcohol or drug dependence;
- Mental disorders or poor compliance;
- Pregnant or lactating women;
- The researcher believes that the subject has a history of other serious systemic diseases or is not suitable to participate in this clinical study due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
This is an open-lable, single-arm, dose escalation and dose extension phase I clinical study of ScTIL designed to observe and evaluate the safety, the tolerance, the pharmacokinetic characteristics and the effectiveness of ScTIL in the treatment of advanced malignant solid tumors, in order to provide the basis for the future clinical research to explore the best recommended phase II dose (PR2D) and treatment scheme.
Read the detailed description
This study consists of two phases: the first phase will be the dose exploration phase (Phase I), followed by the dose extension phase.
In the dose escalation of the study, 3 subjects are enrolled for 1st treatment group, starting with single dose of ScTIL injection of 5x10^9 alone. If there is no dose limiting toxicity (DLT) observed, 3 subjects are enrolled into treatment groups successively in sequential order of: Group 2: ScTIL1.0x10^10; Group 3: ScTIL 2.0x10^10.
After the completion of ScTIL reinfusion for first subject of the 1st dose group, the subject will be observed for no less than 7 days. If no serious toxic and adverse events occurres, ScTIL reinfusion for the second and third subjects will be performed. If no DLT occurres by the 21th days after completion of reinfusion for the 3rd subject, The study will proceed to the next treatment group. If 1/3 of enrolled subjects have DLT, another 3 subjects will be enrolled. In any of the dose groups, if less than 1/6 subjects have DLT, subject enrollment for the next treatment group will start. If DLT occurs in more than 2/6 of subjects, the number of subjects in the previous dose group will be reviewed. If there were only 3 subjects, 3 more subjects will be enrolled. If DLT occurs in less than 1/6 subjects, the dose will be defined as the maximum tolerable dose (MTD), and the dose escalation phase of the study will be completed. If DLT occurs in more than 2/6 subjects in the first dose group, a dose reduction exploration will be performed or the study will be terminated upon decision made by the Safety Committee.
Appropriate doses will be selected by investigator for the dose extention phase study.
- Being tested
- ScTIL injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScTIL injectionBiological
Peripheral blood mononuclear cells (PBMCs) obtained via apheresis are used for cell preparation. PD-1 positive T cells are isolated from PBMCs, are transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor", and cell number are amplified. The obtained ScTIL is used for one-time intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| ScTIL injection | Experimental | In the dose escalation of the study, starting with the dose of injection of 5x10^9. If there is no DLT, followed by the second dose of 1.0x10^10 until the third dose of 2.0x10^10. Receives: Biological: ScTIL injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Including cases of PR and of CR
Measured: 12 weeks after single dose of cell reinfusion
Secondary outcomes (6)
Disease Control Rate (DCR)
The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases
Measured: 12 weeks after the single dose of cell reinfusion
Duration of Response (DOR)
Time from complete remission (CR) or partial remission (PR) to disease progression (PD), death or last tumor evaluation
Measured: 12 weeks after single dose of cell reinfusion
Progression-Free Survival (PFS)
From the beginning of cell therapy to the time of the first disease progression or death due to any cause
Measured: 12 weeks after single dose of cell reinfusion
Overall survival (OS)
Time from cell reinfusion to death due to any cause
Measured: From single dose of cell reinfusion to death
Adverse events (AEs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events V5.0(CTCAE V5.0)
Measured: 24 weeks after single dose of cell reinfusion
Detection of Lentivirus Copy Number
Dynamic changes of carrier gene copy number in peripheral blood
Measured: 12 weeks after single dose of cell reinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Tumor of Digestive Tract or Urinary SystemStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing ChineoMedical Technology Co., Ltd
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, Prof. Dr., Principal investigator, Department of oncology, Cancer hospital of Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499715
- Sponsor's protocol ID
- ScTIL-008-2022
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy of ScTIL Injection (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05499715
- Acronym / sponsor ID
- ScTIL-008-2022
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing ChineoMedical Technology Co., Ltd
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 12 Aug 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.
This is an open-lable, single-arm, dose escalation and dose extension phase I clinical study of ScTIL designed to observe and evaluate the safety, the tolerance, the pharmacokinetic characteristics and the effectiveness of ScTIL in the treatment of advanced malignant solid tumors, in order to provide the basis for the future clinical research to explore the best recommended phase II dose (PR2D) and treatment scheme.
Detailed description
This study consists of two phases: the first phase will be the dose exploration phase (Phase I), followed by the dose extension phase.
In the dose escalation of the study, 3 subjects are enrolled for 1st treatment group, starting with single dose of ScTIL injection of 5x10^9 alone. If there is no dose limiting toxicity (DLT) observed, 3 subjects are enrolled into treatment groups successively in sequential order of: Group 2: ScTIL1.0x10^10; Group 3: ScTIL 2.0x10^10.
After the completion of ScTIL reinfusion for first subject of the 1st dose group, the subject will be observed for no less than 7 days. If no serious toxic and adverse events occurres, ScTIL reinfusion for the second and third subjects will be performed. If no DLT occurres by the 21th days after completion of reinfusion for the 3rd subject, The study will proceed to the next treatment group. If 1/3 of enrolled subjects have DLT, another 3 subjects will be enrolled. In any of the dose groups, if less than 1/6 subjects have DLT, subject enrollment for the next treatment group will start. If DLT occurs in more than 2/6 of subjects, the number of subjects in the previous dose group will be reviewed. If there were only 3 subjects, 3 more subjects will be enrolled. If DLT occurs in less than 1/6 subjects, the dose will be defined as the maximum tolerable dose (MTD), and the dose escalation phase of the study will be completed. If DLT occurs in more than 2/6 subjects in the first dose group, a dose reduction exploration will be performed or the study will be terminated upon decision made by the Safety Committee.
Appropriate doses will be selected by investigator for the dose extention phase study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ScTIL injection | Experimental | Biological: ScTIL injectionIn the dose escalation of the study, starting with the dose of injection of 5x10^9. If there is no DLT, followed by the second dose of 1.0x10^10 until the third dose of 2.0x10^10. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 and ≤ 75, regardless of gender;
- Eastern United States Cancer Collaborative Group (ECOG) physical condition score is 0 to1;
- Anticipated survival > 3 months;
- Advanced digestive tract tumor or urinary system tumor confirmed by histology or cytology;
- Patients with unresectable locally advanced or metastatic malignant digestive or urinary system tumors who have failed at least the first-line standard treatment;
Key exclusion criteria (28 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, so it is not suitable to be included in the study according to the judgment of the researcher;
- Patients who had in recent 5 years or currently have other malignant tunors, except for cured basal cell skin cancer, in situ cervical carcinoma, and in situ lung cancer, before signing the ICF;
- Patients who received PD-L1 monoclonal antibody treatment within 12 weeks before apheresis (including but not limited to atilizumab and dovalizumab);
- There was active infection within 1 week before apheresis, and systemic anti-infection treatment was currently required;
- Currently suffering from interstitial lung disease;
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 |
|---|---|---|
| ScTIL injectionPeripheral blood mononuclear cells (PBMCs) obtained via apheresis are used for cell preparation. PD-1 positive T cells are isolated from PBMCs, are transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor", and cell number are amplified. The obtained ScTIL is used for one-time intravenous infusion. | Biological | ScTIL injection |
Primary outcome
Objective Response Rate (ORR)
Time frame: 12 weeks after single dose of cell reinfusion
Including cases of PR and of CR
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: 12 weeks after the single dose of cell reinfusion
Duration of Response (DOR)
Time frame: 12 weeks after single dose of cell reinfusion
Progression-Free Survival (PFS)
Time frame: 12 weeks after single dose of cell reinfusion
Overall survival (OS)
Time frame: From single dose of cell reinfusion to death
Adverse events (AEs)
Time frame: 24 weeks after single dose of cell reinfusion
Detection of Lentivirus Copy Number
Time frame: 12 weeks after single dose of cell reinfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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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.
Aiping Zhou, Prof. Dr. principal investigator
Department of oncology, Cancer hospital of Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ScTIL injection in people with Advanced Tumor of Digestive Tract or Urinary System, run by Chinese Academy of Medical Sciences 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 15 inclusion and 28 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 12 Aug 2022. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Objective Response Rate (ORR) (time frame: 12 weeks after single dose of cell reinfusion). 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 12 Aug 2022.