A Study of GC203 TIL in Advanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics
About this trial
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
Absolute Neutrophil Count (ANC)≥1.0×10^9/L;
Absolute Lymphocyte Count(ALC)≥0.5×10^9/L;
Platelet≥80×10^9/L；
Disqualifiers
Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
Patients who have received systemic antitumor therapy within 4 weeks.
Patients who have had another primary malignancy within the previous 5 years
Trial design
Design model
Single group
Treatments tested in this trial
Engineering Tumor Infiltrating Lymphocytes
Biological/VaccineA tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximal Tolerance Dose
Time frame
Up to Day 282
Dose Limiting Toxicity
Time frame
Up to Day 283
Adverse Events
Time frame
Maximum 360 daysSecondary outcomes
1
Objective Response Rate
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
Time frame
Every 6 weeks for 12 months2
Duration of Response
Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST
Time frame
Every 6 weeks for 12 months3
Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time frame
Every 6 weeks for 12 months4
Progression-Free Survival
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
Time frame
Every 6 weeks for 12 monthsSponsors and contacts
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Source ClinicalTrials.gov