Immunotherapy for the Treatment of Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTongji Hospital
About this trial
The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be ≥ 18 years of age at the time of consent.
Must have recurrent, metastatic, or persistent carcinoma that is not amenable to curative treatment with surgery and/or radiation therapy and for which no other therapies are expected to have significant benefit, in the opinion of the Investigator.
Must have at least 1 lesion that is resectable for TIL generation. The resected TIL generating lesion(s) should yield at least 1.5 cm in diameter post-resection of tumor tissue. Following resection for TIL generation, must have a remaining measurable target lesion as defined by RECIST v1.1.
Patients must have progressive disease while receiving or after the completion of the most recent prior treatment.
Disqualifiers
Patients who have received an organ allograft or prior cell transfer therapy.
Patients who are on a systemic steroid therapy > 10 mg of prednisone daily or other steroid equivalent.
Patients who currently have prior therapy-related toxicities greater than Grade 1 according to NCI-CTCAE v4.03; except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment/resection.
Patients who have a contraindication to or history of hypersensitivity reaction to any component or excipients of the TIL therapy and the other study drugs.
Trial design
Design model
Single group
Treatments tested in this trial
TIL
Biological/VaccineOn day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)
Aldesleukin
DrugIL-2 125,000 IU/kg/day IV (based on total body weight) beginning within 24 hours of cell infusion and continuing for up to 2 weeks
Cyclophosphamide
DrugOn day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
Fludarabine
DrugDays -5 to -1: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TIL,IL-2,Cyclophosphamide,FludarabineExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Objective Responce Rate [Time Frame: 24 months after cell infusion]
The Objective Responce Rate of patients received immunotherapy are accesed by the Response Criteria in Solid Tumors (RECIST) v1.0.
Time frame
24 months after cell infusionSecondary outcomes
1
Adverse Event
Aggregate of all adverse events, as well as their frequency and severity are accessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.03).
Time frame
up to 24 months2
Disease Control Rate
Disease control rate (DCR) as measured by RECIST 1.1 criteria.
Time frame
up to 24 months3
Duration of Response
Duration of response (DOR) as measured by RECIST 1.1 criteria .
Time frame
up to 24 months4
Progression-Free Survival
PFS will be summarized using Kaplan-Meier estimates.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov