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

NCT04919616 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-09

No results posted yet for this study

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）.

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

TILs（Tumor Infiltrating Lymphocytes）

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

Sponsors & Collaborators

  • Shanghai OriginCell Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-06-15
Completion
2025-06-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919616 on ClinicalTrials.gov