Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.
ConditionAdvanced Solid Tumors Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGritbio Medicine, Inc.
About this trial
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
Eligibility criteria
Qualifiers
1 Age 18~70 years old;
2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
3 At least one lesion that is resectable for the preparation of autologous TIL cells;
4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
Disqualifiers
1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
2 Bleeding events within 3 months prior to screening
3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
Trial design
Treatments tested in this trial
- GT201
- IL-2 and PD-1
Treatment groups
63 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov