Trials / Unknown
UnknownNCT04919616
An Exploratory Clinical Study of TILs in the Treatment of Recurrent / Refractory Non-small Cell Lung Cancer (NSCLC)
An Exploratory Clinical Study of Autologous Tumor Infiltrating Lymphocytes (TILs) in the Treatment of Recurrent and Refractory Non-small Cell Lung Cancer (NSCLC)
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Shanghai OriginCell Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TILs（Tumor Infiltrating Lymphocytes） | 10e9, 10e10, 10e11 dose range of TILs, 3+3 dose escalation |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2023-06-15
- Completion
- 2025-06-15
- First posted
- 2021-06-09
- Last updated
- 2021-06-09
Source: ClinicalTrials.gov record NCT04919616. Inclusion in this directory is not an endorsement.