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

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

INTRODUCTION

  • Org Study ID: HRYZ MASCT-I-1001
  • Secondary ID: N/A
  • NTC ID: NCT03034304
  • Sponsor: 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

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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Treatment-Emergent Adverse Events(Safety)

Primary Outcome 1 - Timeframe: the first 4 weeks

CONDITION

  • Advanced Cancer
  • Bladder Cancer
  • Soft Tissue Sarcoma

ELIGIBILITY


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.

Gender: All

Minimum Age: 70 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ruihua Xu, Doctor

Role: Principal Investigator

Affiliation: Sun Yat-sen University

Overall Contact

Name: Ruihua Xu, Doctor

Phone: 8613924615386

Email: chenping@shhryz.com

LOCATION

Facility Status Contact
Facility: Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
China
Status: Recruiting Contact:
xu yizhou, master

xiyizhou@shhryz.com