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Carcinoma, Non-Small-Cell LungEarly Phase 1NCT04919616

An Exploratory Clinical Study of TILs in the Treatment of Recurrent / Refractory Non-small Cell Lung Cancer (NSCLC)

A Early Phase 1 study testing TILs（Tumor Infiltrating Lymphocytes） in people with Carcinoma, Non-Small-Cell Lung, run by Shanghai OriginCell Therapeutics Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is an open, single-arm, dose-escalating phase I exploratory clinical trial to observe the safety, tolerability and preliminary efficacy of different doses of TILs in the treatment of relapsed and refractory NSCLC（Non-small cell lung cancer）. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
TILs（Tumor Infiltrating Lymphocytes）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
15 Jun 2021to 15 Jun 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To participate in clinical trials and sign an informed consent form voluntarily;
  • 18-70 years old;
  • ECOG (Eastern Cooperative Oncology Group) score is 0 or 1;
  • The patient's pre-survival period exceeds 3 months;
  • Patients with advanced stage IIIB or above (according to AJCC 8th Edition lung cancer staging criteria), and patients with stage IIIA or above who received targeted drugs or PD-1 treatment then failed;
  • Patients who have received systemic therapy of anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, biotherapy or targeted therapy), and whose progress has been confirmed after treatment;
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  • At least one measurable target lesion defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumours);
  • At least one tumor with a diameter of more than 10 mm and a volume of 1.5 cm3 can be resected or biopsied, and TILs can be separated after resection, or TILs can be separated from malignant effusion;
  • Blood routine test reached the following indicators: lymphocyte count ≥ 0.4 × 109 / L, neutrophils ≥ 1.0 × 109 / L, platelet ≥ 60 × 109 / L, hemoglobin ≥ 60g / L;
  • Liver and kidney function: ALT (alanine aminotransferase) or AST (aspartate aminotransferase) index < 2.5 times of normal value; Creatinine clearance rate > 50 ml / min; Total bilirubin < 1.5 times of normal value; Prothrombin time prolongation ≤ 4 s;
  • No heart disease or coronary heart disease, echocardiogram shows normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no serious arrhythmia;
  • Treatment methods for malignant tumors, including radiotherapy, chemotherapy and biological agents (including granulocyte colony-stimulating factor G-CSF, targeted drug therapy, etc.), must be stopped 14 days before obtaining tumor tissue;
  • Female patients with fertility must have a negative pregnancy test;
  • The fertile person or fertile partner must be willing to use an approved and effective contraceptive method during the treatment period and within 12 months after receiving all treatments related to the treatment regimen.

Who cannot join

  • Patients with a history of allergy to any component of the study drug;
  • Patients with symptomatic and/or untreated brain metastases;
  • Patients receiving systemic steroid therapy with prednisone or other steroid equivalent ≥ 10 mg / day. Patients with adrenocortical insufficiency receiving prednisone or other steroid equivalent ≤ 10 mg / day may be eligible;
  • Patients who received live or attenuated vaccines within 28 days before the start of treatment;
  • Patients who have received anti-cancer chemotherapy, radiotherapy or other medications within 2 weeks before screening;
  • Patients who participated in another interventional clinical study within 3 weeks before screening;
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  • Patients with other primary malignant tumors in the past 3 years;
  • Patients who underwent organ transplantation or cell transplantation in the past 20 years;
  • Active infections requiring systemic treatment;
  • The subjects with positive HBsAg or HBcAb and more than 100 copies / L of HBV DNA in peripheral blood; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis antibody was positive in the first screening;
  • Active or previously recorded autoimmune or inflammatory diseases;
  • Patients with any form of primary or acquired immunodeficiency;
  • Patients with inherited or acquired coagulation disorders;
  • Patients with uncontrollable brain metastasis, spinal cord compression, cancerous meningitis within 8 weeks before the first medication, or brain or leptomeningeal disease detected by CT or MRI during screening;
  • Serious mental illness can hinder the full informed consent;
  • Breast feeding female patients;
  • Any investigator decides that it is not appropriate to participate in this trial.

About this study

Official title: An Exploratory Clinical Study of Autologous Tumor Infiltrating Lymphocytes (TILs) in the Treatment of Recurrent and Refractory Non-small Cell Lung Cancer (NSCLC)

This study is an open, single-arm, dose-escalating phase I exploratory clinical trial to observe the safety, tolerability and preliminary efficacy of different doses of TILs in the treatment of relapsed and refractory NSCLC（Non-small cell lung cancer）.

The study includes 7 stages: ① screening period; ② tissue collection; ③ TILs cell production and preparation; ④ lymphocyte depletion pretreatment; ⑤ TILs cell infusion; ⑥ safety and efficacy evaluation; ⑦ follow-up.

Being tested
TILs（Tumor Infiltrating Lymphocytes）
Keywords
Lymphocytes, Tumor-Infiltrating; TILs, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TILs（Tumor Infiltrating Lymphocytes）Drug

    10e9, 10e10, 10e11 dose range of TILs, 3+3 dose escalation

Study groups in NCT04919616
Study groupRoleWhat they receive
Single-armExperimentalNot described
Receives: Drug: TILs（Tumor Infiltrating Lymphocytes）

What is being measured

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

  1. DLT（Dose limiting toxicity）

    The severity of adverse events is graded according to NCT-CTCAE version 5.0, and the investigator will determine whether the subject has DLT. DLT is defined as: Grade 3 or above (CTCAE version 5.0) possible or confirmed related symptoms, laboratory toxicity and clinical events caused by the study treatment within 28 days after transfusion of TILs cells.

    Measured: 28 days

Secondary outcomes (5)

  1. Objective Response Rate, ORR

    To evaluate the efficacy of TILs in patients with NSCLC based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 3 Months

  2. Duration of Response, DOR

    To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1

    Measured: 2 years

  3. Progression-Free Survival, PFS

    To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1

    Measured: 2 years

  4. overall survival, OS

    To evaluate overall survival (OS) in patients with NSCLC

    Measured: 2 years

  5. Disease Control Rate, DCR

    To evaluate the efficacy of TILs in patients with NSCLC by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1

    Measured: 2 years

Timeline

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

  1. First posted9 Jun 2021
  2. Study start15 Jun 2021 (estimated)
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion15 Jun 2025 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919616
Sponsor's protocol ID
Origincell-TIL-003
Status last verified
Jun 2021
First submitted
11 May 2021
Last updated
9 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing TILs（Tumor Infiltrating Lymphocytes） in people with Carcinoma, Non-Small-Cell Lung, run by Shanghai OriginCell Therapeutics Co., Ltd..

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 14 inclusion and 17 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 9 Jun 2021. 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?

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?

DLT（Dose limiting toxicity） (time frame: 28 days). 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 NCT04919616.

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 9 Jun 2021.

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