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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
Sponsor:
Collaborator:
HRYZ (ShenZhen) Biotech Co.
Information provided by (Responsible Party):
SYZ Cell Therapy Co..

Brief Summary:
The purpose of this study is to determine whether the MASCT-I alone and in combination with chemotherapy drug are safe and effective in the treatment of advanced bladder cancer and soft tissue sarcoma

Condition or disease Intervention/treatment Phase
Advanced Cancer Bladder Cancer Soft Tissue Sarcoma Biological: MASCT-I Drug: Ifosfamide Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Overall Survival (OS) [ Time Frame: up to 96 weeks ]
    From enrollment to death of patients

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • written informed consent
  • Life expectancy≥ 6 months
  • Scored 0 -1 on ECOG
  • Results of blood test and biochemistry at baseline meeting the following criteria:Hemoglobin≥85g/L,Leucocyte≥3.0×109/L,Absolute neutrophil count(ANC)≥1.5×109/L,Trombocyte≥70×109/L,ALT/AST ≤ 2.5×ULN or ≤ 5×ULN for patients with hepatic metastases, ALP≤2.5 times of upper limit of normal, Serum total bilirubin < 1.5×ULN,Serum urea nitrogen and creatinine ≤ 1.5×ULN, Serum albumin ≥30g/L
  • The following criteria should also be met by the patients in Group A;

    1. Patients who suffer from advanced (unresectable) or recurrent solid tumors (only limited to bladder cancer and soft tissue sarcoma) confirmed by histology and cytology and are treated unsuccessfully with various standard therapies.
    2. According to RECIST1.1 criteria, there must be one measurable focus;
    3. Time interval between end of other anti-tumor measures and this study treatment is at least 1 month;
  • Patients to be enrolled in group B should also meet the following criteria:

    1. Bladder cancer: confirmed by histology and cytology, advanced recurrent or metastatic. GP chemotherapy could realize clinical benefit.
    2. Soft tissue sarcoma: confirmed by histology and cytology, advanced recurrent or metastatic.Clinical benefit could be achieved after MAID or CAV/IE first-line chemotherapy with predominant Doxorubicin.

Note: Clinical benefits referred to that patients reached the complete remission (CR), partial remission (PR) or stable disease (SD) after treatment.

Major Exclusion Criteria:

  • Participation in the planning or implementation of this study (including the employees of HRYZ and the staff of the study center);
  • Enrollment for another clinical study at the same time, unless it is an observational (non-interventional) clinical study;
  • Possibility of receiving other systemic anti-tumor treatment during this study;
  • Being pregnant or planning to become pregnant;
  • Refusal to provide blood samples;
  • Known allergy to sodium citrate;
  • A medical history of allogenic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, but excluding corneal transplantation);
  • Subjects who present clinical symptom of central nervous system metastases (such as encephaledema, need of hormone intervention or brain metastasis progression);
  • Subjects who are using immunosuppressant, or systemic, or absorbable local steroid therapy for the purpose of immunosuppression;
  • Subjects who previously received MASCT or other cellular immunotherapy;
  • Active tuberculosis;
  • Any major operation (to be defined by the investigator) within 28 days before administration of the first investigational treatment;
  • Active infections, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection;
  • Presence of peripheral nervous system disorders, or a history of apparent metal disorders and central nervous system disorders;
  • Severe hepatic (e.g., liver cirrhosis, etc.), renal, respiratory diseases, or non-communicable diseases such as uncontrolled diabetes, hypertension, etc.;
  • Other malignant tumors within the last five years, excluding non-melanoma skin cancer and carcinoma in situ.

Information from the National Library of Medicine

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


Contacts
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Contact: Ping Chen, Master 8613924615386 chenping@shhryz.com
Contact: yizhou xu, master xuyizhou@shhryz.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: xu yizhou, master       xiyizhou@shhryz.com   
Principal Investigator: xu ruihua, doctor         
Sponsors and Collaborators
SYZ Cell Therapy Co..
HRYZ (ShenZhen) Biotech Co.
Investigators
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Principal Investigator: Ruihua Xu, Doctor Sun Yat-sen University

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Responsible Party: SYZ Cell Therapy Co..
ClinicalTrials.gov Identifier: NCT03034304     History of Changes
Other Study ID Numbers: HRYZ MASCT-I-1001
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SYZ Cell Therapy Co..:
MASCT-I,DC,T cell
Advanced solid tumors
Bladder Cancer
Soft Tissue Sarcoma

Additional relevant MeSH terms:
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Sarcoma
Urinary Bladder Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents