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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

April 30, 2032

Study Completion Date

April 30, 2035

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 60 mg/kg IV daily over approximately two hours for two days. Cyclophosphamide will be initiated seven days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.

DRUG

Fludarabine

After administration of cyclophosphamide, fludarabine will then be infused at 25 mg/m\^2 intravenous piggyback (IVPB) daily over approximately 30 minutes for five days, starting five days prior to LNL transfer.

BIOLOGICAL

Tumor-draining lymph node-derived lymphocyte (LNL)

"In the dose-escalation portion of phase I study, participants receive ascending dose (1×10\^9\~18×10\^9), single Infusion of LNL on day 0. In the dose-expansion portion of phase I study, participants receive single infusion of LNL at the recommended phase 2 dose (RP2D).~In the phase II study, participants receive single infusion of LNL at the 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 fixed dose of 200mg IV on Day 1 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Nab-paclitaxel

Nab-paclitaxel will be administered at 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Gemcitabine

Gemcitabine will be administered at 1000 mg/m\^2 IV on Days 1 and 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Carboplatin

Carboplatin will be administered at area under the concentration-time curve 2 (AUC 2) IV on Days 1 and 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.

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