Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2031

Conditions
Breast Neoplasms
Interventions
PROCEDURE

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.

DRUG

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.

DRUG

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.

BIOLOGICAL

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).

BIOLOGICAL

Interleukin-2

Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV.

BIOLOGICAL

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.

DRUG

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.

Trial Locations (1)

510120

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER