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
Qualifiers
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
Treatments tested in this trial
- TIL
- Aldesleukin
- Cyclophosphamide
- Fludarabine
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov