A Phase II Study of GC101 in NSCLC
ConditionNon Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Juncell Therapeutics
About this trial
28 participants are expected to be enrolled for the Phase II clinical trial, this trial is expected to be finished in 36 months.
Eligibility criteria
Qualifiers
1. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
2. Aged ≥18 years and ≤70 years, regardless of gender;
3.Patients with non-small cell lung cancer who have been confirmed negative for EGFR mutations, ALK, and ROS-1 by prior genetic testing, meeting one of the following criteria:(1) If the patient is known to carry one or more other actionable genetic mutations (e.g., KRAS G12C mutation, BRAF V600 mutation, MET exon 14 skipping mutation, HER-2 mutation, RET fusion, NTRK fusion), the patient must have received at least one approved targeted therapy, and the investigator considers that additional targeted therapy would not be in the best interest of the study participant. In addition, the patient must have experienced failure of platinum-based chemotherapy.
4. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be >150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;
Disqualifiers
1. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;
2. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;
3.Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
4.Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);
Trial design
Treatments tested in this trial
- Autologous Tumor Infiltrating Lymphocytes
Treatment groups
28 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov