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Malignant Solid TumorPhase 1/2NCT04571892

A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

A Phase 1/2 study testing Super circulating tumor infiltrating lymphocytes(ScTIL) in people with Malignant Solid Tumor, run by Shanghai East Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210 in the treatment of malignant Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Solid Tumor
What is being tested?
Super circulating tumor infiltrating lymphocytes(ScTIL)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
2 sitesChina
Study dates
15 Oct 2020to Dec 2024
Phase
Phase 1/2
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

  • When patients meet ALL of the following requirements, they will be eligible to be recruited, at their own wills, to participate in the clinical study.
  • Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
  • An expected survival duration of longer than 3 months;
  • Patients with malignant solid tumor as confirmed by histology or cytology who failed in their prior standard therapies , or there is no recommended standard treatment, or a standard treatment is not applicable at this time;
  • The proportion of PD-1 positive T lymphocytes to the total T lymphocytes is ≥ 18%. For patients who received PD-1 monoclonal antibody treatment within 4 weeks before screening, the proportion of PD-1 positive T to the total T lymphocytes is ≥ 12%;
  • In accordance to RECIST version 1.1, there is at least one evaluable tumor focus for dose escalation phase; or there is at least one measurable tumor focus for dose expansion stage;
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  • ECOG physical status score of between 0 to 1;
  • Sufficient bone marrow and organ function; Blood system:no transfusion or hematopoietic stimulating factor treatment within 14 days; Neutrophil count (ANC): ≥ 1.5 × 109/L; Platelet (PLT): ≥ 75 × 109/L; Hemoglobin (HB): ≥ 90 g/L; Absolute lymphocyte count (lym): ≥60% of the lower limit of normal range; Lymphocyte subsets:Percentage of B lymphocyte (CD19+) to the total lymphocyte of ≥9%； Liver function Total bilirubin (TBIL) : ≤ 1.5 × ULN Alanine aminotransferase (ALT): ≤ 3 × ULN; for patients with liver metastasis or liver cancer: ≤ 5 × ULN Aspartate aminotransferase (AST)： ≤ 3 × ULN; for patients with liver metastasis or liver cancer: ≤ 5 × ULN Renal function：Creatinine ≤ 1.5 × ULN Coagulation function：Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN ；International normalized ratio (INR) ≤ 1.5 × ULN
  • Eligible fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the trial and at least 90 days after the last medication; women of childbearing age (as defined in Appendix 8) must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug;
  • The subjects should be informed of the study before the trial and sign the written informed consent voluntarily.

Who cannot join

  • When a patient has one of the following conditions, he or she will not be eligible to be recruited to the clinical study.
  • Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before apheresis procedure, except for the following items:
  • Nitrosourea or mitomycin C treatment was within 6 weeks before apheresis;
  • Oral administration of fluorouracil and small molecule targeted drugs was one week before apheresis.
  • Received other unlisted clinical research drugs or treatments within 4 weeks before ;
  • Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before apheresis, or a surgery was scheduled during the trial period;
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  • Received systemic corticosteroids (prednisone > 10mg/day or equivalent dose of the similar drugs) or other immunosuppressants within 14 days before apheresis; Except for the following: topical, ocular, intra articular, nasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment (e.g., prevention of contrast media allergy);
  • Received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc. within 14 days apheresis;
  • Received live attenuated vaccine within 4 weeks before apheresis;
  • The adverse reactions from previous anti-tumor therapy have not yet restored to CTCAE 5.0 grade evaluation of ≤1 (except for the toxicity without safety risk as judged by researchers such as alopecia).
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that the central nervous system metastasis or meningeal metastasis has not been controlled, as judged by researcher inappropriate to be recruited to the study;
  • Patients with active infection within one week before apheresis and a systemic anti-infection treatment is essential at this time;
  • History of immunodeficiency, including positive HIV antibody test;
  • Hepatitis B (HBsAg positive and/or a positive hepatitis C antibody and/or a positive treponema pallidum antibody;
  • Patients with progressive interstitial pneumonitis;
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • There are serious cardiac arrhythmia or conduction abnormalities, such as 2-3 degree ventricular arrhythmia, , atrioventricular block, and so on.
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration.
  • New York Heart Association (NYHA) defined cardiac function grade ≥ II or left ventricular ejection fraction (LVEF) of less than 50%, or as judged by other researchers to have a high risk of structural heart disease;
  • Clinically uncontrollable hypertension.
  • Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid disease and well controlled type I diabetes mellitus;
  • Received immunotherapy and had Irae of grade 3 or above;
  • The serous cavity exudation which could not be controlled clinically was not suitable for the study;
  • Known alcohol or drug dependence;
  • Mental disorder or poor compliance;
  • Pregnant or lactating women;
  • The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.

Trial locations and contacts

2 sites in 1 country.

Jin Li, MD,PhD contact

+86 ext. 13761222111

lijin@csco.org.cn

Junli Xue, MD,PhD contact

+86 ext. 13764694939

13764694939@163.com

China2 sites, 2 recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200126

    Jin Li, MD, PhD, 86 ext. 13761222111, lijin@csco.org.cn

    Recruiting

  • Shanghai Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Yuhong Zhou, MD, PhD, 13918286810, zhou.yuhong@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Single-arm, Single-dose Escalation and Multiple-dose Expansion Clinical Study of Cell Therapy to Evaluate the Tolerance, the Pharmacokinetic Characteristics, the Safety, and the Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210 in the treatment of malignant

Being tested
Super circulating tumor infiltrating lymphocytes(ScTIL)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Super circulating tumor infiltrating lymphocytes(ScTIL)Biological

    Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor". The obtained ScTIL is used for one-time intravenous infusion.

Study groups in NCT04571892
Study groupRoleWhat they receive
ScTIL210ExperimentalThis trial is designed single arm. All the subjects enrolled will receive the experimental intervention, ScTIL210(Super circulating tumor infiltrating lymphocytes).
Receives: Biological: Super circulating tumor infiltrating lymphocytes(ScTIL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety of ScTIL210

    To assess if the ScTIL210 product will be safe to the subjects, as assessed by the incidence of treatment-related adverse events, in the treatment of malignant solid tumors.

    Measured: 24 weeks post infusion

Secondary outcomes (2)

  1. The in vivo dynamic variation of reinfused ScTIL210

    To assess the percentage of PD1 positive cell in total lymphocytes of peripheral blood along a series of time points after reinfusion of ScTIL210 as measured by flow cytometry.

    Measured: 24 weeks post infusion

  2. The efficacy of ScTIL210 in the treatment of malignant solid tumors

    To assess the clinical efficacy of ScTIL210 in the treatment of malignant solid tumors, as assessed by duration of response(DOR), i.e., time from complete remission (CR) or partial remission (PR) to disease progression (PD), or to death, or to last tumor evaluation.

    Measured: 24 weeks post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start15 Oct 2020
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571892
Sponsor's protocol ID
ScTIL210-003-2020
Status last verified
Apr 2023
First submitted
18 Aug 2020
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Super circulating tumor infiltrating lymphocytes(ScTIL) in people with Malignant Solid Tumor, run by Shanghai East Hospital at 2 sites 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 10 inclusion and 27 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jin Li, MD,PhD (+86 ext. 13761222111, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety of ScTIL210 (time frame: 24 weeks post infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571892.

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 Apr 2023.

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