Chidamide Bridging for CAR-T Therapy

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 25, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2025

Conditions
Non Hodgkin's Lymphoma
Interventions
DRUG

Chidamide

"1. Chidamide monotherapy mode: Chidamide was administered for at least 6 times after leukapheresis, 10mg oral D1-4, 20mg oral D7 every 3 days to the beginning day of FC conditioning.~2. Chidamide combination mode: The combination of one or more of the following drugs in addition to chidamide is permitted: glucocorticoids, BTK inhibitors, chemotherapy, other previously used resistance drugs, etc."

DRUG

Fludarabine and cyclophosphamide

Patients should be received FC regimen conditioning 3 to 5 days prior to CAR-T cell infusion. The recommended regimen is intravenous fludarabine (25-30 mg/m\^2) and cyclophosphamide (250-500 mg/m\^2) daily for 3 consecutive days. The clinician may also adjust the cleansing regimen according to the patient's actual situation.

BIOLOGICAL

Anti-CD19 CAR-T cells

A single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 100 × 10\^6 for Relma-cel or 2 × 10\^6/kg for Axi-cel. Other commercial CAR-T doses are determined by specific drug infusion instructions. The dose of experimental CAR-T was determined by the investigator. Infusion volume was calculated based on CAR-T cell density and recommended dose.

Trial Locations (13)

Unknown

RECRUITING

Beijing Tongren Hospital, Capital Medical University, Beijing

RECRUITING

Peking Union Medical College Hospital, Beijing

RECRUITING

Peking University Cancer Hospital, Beijing

RECRUITING

Zhujiang Hospital of Southern Medical University, Guangzhou

RECRUITING

Sun Yat-Sen University Cancer Hospital, Guangzhou

RECRUITING

Tongji Hospital, Tongji Medical College of HUST, Wuhan

RECRUITING

Xiehe Hospital, Tongji Medical College of HUST, Wuhan

RECRUITING

Tongji Hospital of Tongji University, Shanghai

RECRUITING

West China Hospital of Sichuan University, Chengdu

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

RECRUITING

Tianjin Medical University Cancer Institute and Hospital, Tianjin

RECRUITING

The First Affiliated Hospital of Zhejiang University, Hangzhou

RECRUITING

Biotherapeutic Department, Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER