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A Phase II Study of GC101 in NSCLC

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Autologous Tumor Infiltrating Lymphocytes

    Biological/Vaccine

    A tumor sample is resected from each participant and cultured ex vivo to generate tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC101 TIL followed low-dose PD-1 antibody.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: GC101 TILExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria)

Time frame
18 weeks
2

Progression-Free Survival

Evaluate the efficacy endpoints of PFS by the investigator with RECIST

Time frame
Maximum 36 months

Secondary outcomes

1

Disease Control Rate

Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

Time frame
Maximum 36 months
2

Duration of Response

Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

Time frame
Maximum 36 months
3

Overall survival

Evaluate the efficacy endpoints of OS

Time frame
Maximum 60 months
4

Adverse Events

Incidence of adverse events associated with GC101 TIL infusion

Time frame
Maximum 360 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Juncell Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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