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MelanomaPhase 1NCT04357509

The Tolerance,Pharmacokinetic Characteristics,Safety and Efficacy of ScTIL210 in the Treatment of Melanoma

A Phase 1 study testing Super circulating tumor infiltrating lymphocytes(ScTIL) in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-lable, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and evaluate the tolerance, pharmacokinetic characteristics, safety and efficacy of ScTIL210（Super circulating tumor infiltrating lymphocytes）in the treatment of Melanoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Melanoma
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
32 participants
Where
1 siteChina
Study dates
May 2020to Dec 2021
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 70 years old (inclusive), regardless of gender.
  • Expected survival duration is greater than three months.
  • Patients with acral and mucosal melanoma confirmed by histology or cytology.
  • Disease progression after previous first-line system treatment or intolerance during the treatment. Intolerance includes the following:
  • Incompetence of major organ function restoration of the subject as judged by the investigator.
  • The subjects experienced Grade 3 non-hematological toxicity or Grade 4 hematological toxicity during treatment (Grade 3 thrombocytopenia).
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  • The subjects refuse the optional first-line treatment.
  • Subjects voluntarily accept peripheral blood apheresis to obtain cells for cell preparation. The proportion of peripheral blood PD1(programmed death 1)positive T cells in total T cells is ≥18%. The proportion of peripheral blood PD1 positive T cells in total T cells ratio is ≥12% for the subjects underwent PD1 monoclonal antibody treatment before screening.
  • At least one measurable focal lesion (for efficacy assessment) has been detected by CT or MRI as defined by RECIST v1.1. The measurable tumor lesion is defined as the longest diameter ≥ 10mm and the short diameter of metastatic lymph nodes ≥ 15mm under the condition that the scanning thickness does not exceed 5.0 mm;
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • No serious hematology, liver, and kidney dysfunction, and meet the following laboratory test criteria:
  • 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 50% of the normal lower line;
  • Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both eqal to or lower than 3 times the upper limit of normal (ULN) (if intrahepatic bile duct cancer exists, equal to lower than 5 times of ULN); total bilirubin (TBIL) is equal to or lower than 2 times of ULN;
  • Kidney function: creatinine (Cr) is equal to or lower than 1.5 times of ULN;
  • Coagulation function: prothrombin time (PT) is equal to or shorter than 1.5 times of ULN or activated partial prothrombin time (APTT) is equal to or shorter than1.5 times of ULN;
  • Urine protein concentration is equal to or lower than ≤ 1 +, no edema.
  • Albumin is equal to or higher than 3.0g/dl.
  • At the beginning of screening, the elution period upon completion of anticancer chemotherapies and glucocorticoids (includes hydrocortisone, prednisone, prednisolone, methylprednisolone) should be no shorter than 4 weeks; Palliative radiotherapy is allowed, as long as the selected region(s) of the therapy is/are spatially distinct from that correspondent to designated focus of lesion for efficacy assessment.
  • Male or fertile female subjects are required to take effective contraceptive measures during the treatment as well as within 90 days upon completion of last therapeutic cell reinfusion;
  • Full capability and commitment to abide by clinical research protocols and follow-up procedures.
  • Subjects understand and are willing to abide by the study protocol and to participate in the study by providing signed informed consent form.

Who cannot join

  • Subjects with Uveal/Ocular melanoma.
  • Subjects with symptomatic and/or untreated brain metastases (of any size and number).
  • Subjects with treated brain metastases can be considered for enrollment under the condition that the disease must have remained stable for greater than 14 days before starting screening.
  • Subjects with another primary malignancy within the past 3 years including breast cancer, cervical cancer, bladder cancer in situ, and local prostate cancer);
  • Presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; with exclusion of Asthma subjects who need bronchodilators for medical intervention); however, the following patients are allowed:
  • Vitiligo, psoriasis, hair loss without systemic treatment;
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  • Well-controlled type 1 diabetes;
  • Hypothyroidism with replacement thyroid function.
  • Subjects receiving chronic systemic steroid treatment for any reason; with exception of the low-dose glucocorticoid replacement therapy due to adrenal insufficiency.
  • Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g, corneal transplants, hair transplants).
  • Subjects with any forms of primary immunodeficiency (e.g, severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS])
  • Presence of major acute or chronic infections, including:
  • A known history of positive human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (not required for screening). If the investigator strongly suspects a HIV infection in a subject with no known medical history during the screening period, the subject should be tested for HIV in accordance to the local standard guidelines).
  • Active TB infection (evidences are: clinical symptoms, physical examination and/or medical imaging, and laboratory findings).
  • An active bacterial or fungal infection that requires systemic treatment.
  • Viral hepatitis, including hepatitis B and C, etc.
  • Subjects with syphilis virus positive
  • Acute exacerbation of chronic obstructive pulmonary disease , or other respiratory diseases that requires hospitalization within 30 days prior to enrollment，or that hinders study treatment.
  • Clinically significant cardiovascular or cerebrovascular diseases, such as: cerebrovascular accident or stroke occured within6 months prior to enrollment), myocardial infarction (occured within6 months prior to enrollment), unstable angina, congestive heart failure (equal to or greater than Grade II of New York Heart Association) or severe arrhythmia.
  • Subjects who are incapable tolerate or are allergic to contrast agents of CT scanning or magnetic resonance imaging (MRI).
  • Subjects who participated in other clinical trials within 4 weeks prior to enrollment.
  • Pregnant or lactating women.
  • A history of alcoholic or drug abuse within 2 years (acknowledged via inquiries and previous medical history) prior to enrollment.
  • Other severe acute or chronic diseases, or incompetency/have only restricted competency for civil conduct.
  • Subjects or family members is/are incapable to understand the conditions and goals of the study.

Trial locations and contacts

1 site in 1 country.

Xinan Sheng, Doctor contact

010-88196348

doctor_sheng@126.com

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

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

This is an open-lable, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and evaluate the tolerance, pharmacokinetic characteristics, safety and efficacy of ScTIL210（Super circulating tumor infiltrating lymphocytes）in the treatment of Melanoma.

Conditions
Melanoma
Being tested
Super circulating tumor infiltrating lymphocytes(ScTIL)
Medical subject headings
Melanoma

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 NCT04357509
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. Objective Response Rate(ORR)

    Including cases of CR and PR

    Measured: 24 weeks after the last cell transfusion

Secondary outcomes (6)

  1. Disease Control Rate(DCR)

    The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases

    Measured: 24 weeks after the last cell transfusion

  2. Duration of Response(DOR)

    Time from complete remission (CR) or partial remission (PR) to disease progression (PD), death or last tumor evaluation

    Measured: 24 weeks after the last cell transfusion

  3. 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: 24 weeks after the last cell transfusion

  4. Overall survival(OS)

    Time from cell reinfusion to death due to any cause

    Measured: 24 weeks after the last cell transfusion

  5. Adverse events(AEs)

    According to National Cancer Institute Common Terminology Criteria for Adverse Events V5.0(CTCAE V5.0)

    Measured: 24 weeks after the last cell transfusion

  6. Detection of Lentivirus Copy Number

    Dynamic changes of carrier gene copy number in peripheral blood

    Measured: 24 weeks after the last cell transfusion

Timeline

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

  1. First posted22 Apr 2020
  2. Study startMay 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357509
Sponsor's protocol ID
ScTIL210-002-2019
Status last verified
Apr 2020
First submitted
20 Apr 2020
Last updated
24 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Super circulating tumor infiltrating lymphocytes(ScTIL) in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 21 inclusion and 25 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 24 Apr 2020. 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?

Contact Xinan Sheng, Doctor (010-88196348, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: 24 weeks after the last cell transfusion). 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 NCT04357509.

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 24 Apr 2020.

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