TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors
ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGrit Biotechnology
About this trial
This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
Disqualifiers
1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone) within 14 days before lymphocyte depletion chemotherapy;
3. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
Trial design
Design model
Single group
Treatments tested in this trial
TIL injection
Biological/VaccineAutologous tumor infiltrating lymphocyte injection
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: TIL injection treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection (GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
Time frame
From TIL infusion to the 24th weekSecondary outcomes
1
Objective response rate (ORR)
To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.
Time frame
Up to 24 months post infusion2
Disease control rate (DCR)
To evaluate the percentage of participants that achieved partial response (PR), complete response (CR), or stable disease (SD) after treatment among total number of evaluable patients.
Time frame
Up to 24 months post infusion3
Progression-free survival (PFS)
To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.
Time frame
Up to 24 months post infusion4
Duration of Response (DoR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.
Time frame
Up to 24 months post infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Grit Biotechnology
Lead sponsor
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Source ClinicalTrials.gov