24
Participants
Start Date
November 1, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2031
Surgery for harvesting tumor-draining lymph nodes
A sample of the participant's tumor-draining lymph nodes will be collected and sent to the biotherapy center for LNL isolation and expansion.
Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m\^2 IV daily for three days. Cyclophosphamide will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
Fludarabine
Fludarabine will be administered at 30 mg/m\^2 IV daily for three days. Fludarabine will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
Tumor-draining lymph node-derived lymphocyte (LNL)
In the dose-escalation portion, participants receive ascending dose (1×10\^9\~18×10\^9), single Infusion of LNL on day 0. In the dose-expansion portion, participants receive single infusion of LNL at the recommended phase 2 dose (RP2D).
Interleukin-2
Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV.
Camrelizumab
Camrelizumab will be administered at a dose of 200mg (3mg/kg for participants whose weight is below 50kg) IV on Day 1 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.
Chemotherapeutic drug, ADC or PARP inhibitor
Another anti-tumor drug chosen from chemotherapeutic drug, ADC, or PARP inhibitor will be administered at investigator's discretion.
RECRUITING
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER