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A Phase Ib Study of GC101 in NSCLC

ConditionsNon Small Cell Lung Cancer MetastaticNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Juncell Therapeutics

About this trial

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail 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 unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual 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. More than 5-line system therapy had been used in previous 3 years before screening period.

2. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;

3. 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;

4. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;

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

20 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

Incidence of adverse events associated with GC101 TIL retransfusion

Time frame
Up to Day 28
2

Objective Response Rate

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

Time frame
18 weeks

Secondary outcomes

1

Adverse Events

Incidence of adverse events associated with GC101 TIL retransfusion

Time frame
Maximum 360 days
2

Objective Response Rate

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

Time frame
Maximum 36 months
3

Best overall response

Optimal efficacy recorded from the start of treatment until disease progression or relapse (RECIST v1.1 and iRECIST)

Time frame
Maximum 36 months
4

Disease Control Rate

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

Time frame
Maximum 36 months

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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