A Phase Ib Study of GC101 in NSCLC
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
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
Treatments tested in this trial
- Autologous Tumor Infiltrating Lymphocytes
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov