A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03034304|
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Bladder Cancer Soft Tissue Sarcoma||Biological: MASCT-I Drug: Ifosfamide||Phase 1|
The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is optimized continuously and has been upgraded from the first-generation MASCT technology to MASCT-I. MASCT-I is to add PD1 antibody in vitro cell culture process of MASCT technology to block PD1 receptor on immunocytes, relieving the brake at immunocytes' reinfusion and interaction with tumor cells for enhancing the effectiveness of immunocytes killing tumor cells. At present, the development and validation of manufacturing process has been completed, and it is urgently needed to conduct the validation of clinical effect. This study is primarily to assess the safety and anti-tumor effect of MASCT-I technology to provide a basis for II/III phase clinical trials.
This is a single-center,phase I clinical study for evaluating the safety and efficacy of MASCT-I technology in patients with advanced solid tumors and preliminarily assessing the antitumor effectiveness of MASCT-I alone and in combination with chemotherapy drugs. About 33-36 cases of adult patients with advanced solid tumors (only limited to bladder cancer and soft tissue sarcoma ) are to be recruited.
This study is divided into two stages:
Stage I is a small sample safety observation stage where the "3+3" design including groups A and B. Group A represents the group of MASCT-I alone where patients with advanced solid tumors that various standard therapies failed in clinical practice are included;Group B represents the combination group of MASCT-I plus chemotherapy drug or group of MASCT-I alone where patients with recurrent or metastatic advanced solid tumor who achieved the clinical benefit after chemotherapy (CR, PR, SD) are included.
Stage II is a dose expansion stage to observe the safety and anti-tumor effectiveness. The patients enrolled in the stage II are the same in group B subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-center, I Phase Clinical Study for Evaluating the Safety and Efficacy of Multiple-antigen Specific Cell Therapy in Vitro Combined With Anti-PD1 Technology (MASCT-I) in Patients With Advanced Solid Tumors and Preliminarily Assessing the Antitumor Effectiveness of MASCT-I Alone and in Combination With Chemotherapy Drugs|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: MASCT-I alone or in combination with ifosfamide.
Bladder cancer both two stage and Soft tissue sarcoma of stage I: treatment with MASCT-I alone, conducted until disease progression, intolerance or end of study.
Soft tissue sarcoma of stage II: treatment with MASCT-I in combination with ifosfamide. Treatment with MASCT-I is conducted until disease progression, intolerance or end of study. Ifosfamide is used from the first day after apheresis. If disease progression or intolerance occurred, ifosfamide is stopped.
The final products of MASCT-I technology are dendritic cells (DC) and effector T cells
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
- Incidence of Treatment-Emergent Adverse Events（Safety） [ Time Frame: the first 4 weeks ]All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients obtained in the first treatment cycle of the first course of treatment of the first stage in this study
- Incidence of Treatment-Emergent Adverse Events（Safety） [ Time Frame: up to 96 weeks ]All the local reactions, systemic reactions, all the adverse events and serious adverse events obtained during the study of all the patients included in the first stage and the second stage of this study
- Disease Control Rate (DCR) [ Time Frame: u.p to 96 weeks ]Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria
- Progression-Free Survival (PFS) [ Time Frame: From enrollment to progression of disease. Estimated about 6 months ]The length of time from enrollment until the time of progression of disease
- Overall Survival (OS) [ Time Frame: up to 96 weeks ]From enrollment to death of patients
- Time to recurrence (TTR) [ Time Frame: up to 96 weeks ]the period of time from signing of the ICF by the patient to progression of tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034304
|Contact: Ping Chen, Masteremail@example.com|
|Contact: yizhou xu, firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: xu yizhou, master email@example.com|
|Principal Investigator: xu ruihua, doctor|
|Principal Investigator:||Ruihua Xu, Doctor||Sun Yat-sen University|