A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors

PHASE1TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

November 13, 2023

Study Completion Date

November 13, 2023

Conditions
Advanced Solid Tumors
Interventions
BIOLOGICAL

MASCT-I

The final products of MASCT-I technology are dendritic cells (DC) and effector T cells

DRUG

Ifosfamide

2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles

DRUG

PD1 antibody

200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.

DRUG

Adriamycin

60mg/m2, from the first day of each cycle, it is used for 1-2 days, intravenous drip. Repeat the above cycle after 4 weeks, no more than 8 cycles

DRUG

Gemcitabine

1000 mg/m2, Intravenous drip for about 30 min, used on the first and eighth days of each cycle, and every 3-4 weeks as a cycle

DRUG

Cisplatin

70mg/m2, Use on the first day of each chemotherapy cycle, intravenous drip for 30-120 min, and every 3-4 weeks as a cycle;

DRUG

Carboplatin

5mg/ml/min, Use it on the first day of each chemotherapy cycle, intravenous drip for 30 minutes, and every 3-4 weeks as a cycle

Trial Locations (9)

200032

Zhongshan Hospital Affiliated to Fudan University, Shanghai

510000

Sun Yat-sen University Cancer Center, Guangzhou

Unknown

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

Shanghai Sixth People's Hospital, Shanghai

Shanghai Tenth People's Hospital, Shanghai

Tianjin Cancer Hospital, Tianjin

The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou

Zhejiang Tumor Hospita, Hangzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HRYZ Biotech Co.

INDUSTRY

NCT03034304 - A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter