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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    36
  • sponsor
    SYZ Cell Therapy Co..
Updated on 25 January 2021
cancer
measurable disease
carcinoma
serum bilirubin
doxorubicin
metastasis
chemotherapy drug
liver metastasis
gemcitabine
cancer chemotherapy
solid tumour
solid neoplasm
bladder cancer
ifosfamide
bladder tumor
adriamycin
soft tissue sarcoma

Summary

The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with advanced solid tumors, either alone or in combination with chemical drugs or in combination with PD1 antibody.

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 a technology which add PD1 antibody in vitro cell culture process of MASCT cell culture to block PD1 receptor on immunocytes, release the brake on immunocytes' reinfusion and interaction with tumor cells for enhancing the efficacy 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 data for II/III phase clinical trials.

This is a Multi-center, phase I clinical study to evaluate the safety and tolerability of multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid tumor, and to preliminarily evaluate the anti-tumor efficacy of MASCT-I alone, in combination with chemical drugs, and in combination with PD1 antibody. About 133 cases of adult patients with advanced solid tumors will be recruited.

This study is divided into four groups: Group 1: Bladder cancer and soft-tissue sarcoma with advanced recurrence or metastasis that failed standard treatment: MASCT-I alone will be used.

Group 2: Advanced metastatic or recurrent urothelial carcinoma that achieved clinical benefit after first-line chemotherapy: MASCT-I A; soft tissue sarcoma or osteosarcoma: MASCT-I regimen 1 or MASCT-I regimen 2; advanced metastatic or recurrent cholangiocarcinoma that achieved clinical benefit after first-line treatment: MASCT-I regimen 2

Group 3: Advanced metastatic or recurrent urothelial carcinoma, soft tissue sarcoma/osteosarcoma, and cholangiocarcinoma that progressed after first-line chemotherapy were treated with MASCT-I combined with PD1 antibody until the disease progressed. If disease progression occurs during MASCT-I + PD1 antibody combination therapy, treatment will be discontinued and then go to follow-up.

Group 4: Recurrent metastatic solid tumors that had failed previous treatment with PD1 antibody were treated with MASCT-I regimen 2 combined with PD1 antibody until the disease progressed.

Group 1 is a small sample size safety observation stage where the "3+3" design will be used. It represents the group of MASCT-I alone where patients with advanced solid tumors that various standard therapies failed in clinical practice are included.

Group 2 includes stage I ,stage II and stage III.Stage I is a small sample size safety observation stage where the "3+3" design will be used .Stage I 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.Advanced metastatic or recurrent urothelial carcinoma, soft tissue sarcoma or osteosarcoma ,cholangiocarcinoma scheduled to be enrolled after first-line treatment to achieve clinical benefitCR,PR,SD.If disease progression occured,patients will go to stage III,where MASCT-I + PD1 antibody therapy will be used until disease progressed again.

Details
Condition bladder cancer, Sarcoma, Advanced Solid Tumors, Advanced Cancer, Urothelial Cancer, Sarcoma (Pediatric), Soft Tissue Sarcoma, Bladder Carcinoma
Treatment ifosfamide, MASCT-I, PD1 antibody
Clinical Study IdentifierNCT03034304
SponsorSYZ Cell Therapy Co..
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-70 at screening
Obtain written informed consent of the subject/legal representative prior to conducting any program related procedures, including evaluation during the screening period
Scored 0 -1 on ECOG
Life expectancy 6 months
Cardiopulmonary function is basically normal
Results of blood test and biochemistry at baseline meeting the following criteria:Hemoglobin85g/L,Leucocyte3.0109/L,Absolute neutrophil countANC1.5109/LTrombocyte70109/L,ALT/AST 2.5ULN or 5ULN for patients with hepatic metastases, ALP2.5 times of upper limit of normal, Serum total bilirubin < 1.5ULN,Serum urea nitrogen and creatinine 1.5ULN(except patients with urothelial carcinoma,Serum urea nitrogen and creatinine 2.5ULN), Serum albumin 30g/L
For the first group of subjects, the following criteria should be met
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
According to RECIST1.1 criteria, there must be one measurable focus
Time interval between end of other anti-tumor measures and this study treatment is at least 1 month
For the second group of subjects, the following criteria should be met
Urothelial carcinoma: histologically or cytologically confirmed that gemcitabine + platinum-based first-line chemotherapy achieved clinical benefit after 4-6 cycles of advanced recurrence or metastasis
Soft tissue sarcoma or osteosarcoma: Subjects who histologically or cytologically demonstrated clinical benefit after at least 4 cycles of doxorubicin-based first-line chemotherapy following advanced recurrence or metastasis. For some subjects who are intolerant or insensitive to chemotherapy, screening can also be conducted after other first-line treatment regiments achieve clinical benefit
Cholangiocarcinoma: Histologically or cytologically confirmed, first-line treatment after advanced recurrence or metastasis is beneficial
Note: Clinical benefit is defined as complete response (CR), partial response
(PR), or disease stabilization (SD). The disease stabilizes for more than 2
months
For subjects in the third group, the following criteria should be met
Urothelial carcinoma: histologically or cytologically confirmed disease progression after advanced recurrence or metastasis following gemcitabine + platinum regimen first-line chemotherapy
Soft tissue sarcoma or osteosarcoma: histologically or cytologically confirmed disease progression after advanced recurrence or metastasis followed by first-line chemotherapy dominated by adriamycin; For some subjects who are intolerant or insensitive to chemotherapy, they can also be screened after other first-line treatment regiments fail
Cholangiocarcinoma: histologically or cytologically confirmed, progression after first-line treatment after advanced recurrence or metastasis
According to RECIST1.1, at least one measurable lesion must be present
An interval of at least 4 weeks between the end of other anticancer treatments and the treatment in this study
For the fourth group of subjects, the following criteria should be met
Solid tumor with advanced recurrence or metastasis
PD1 antibody therapy has been used before, and the disease is progressing. The interval between the end of PD1 antibody therapy and this study is at least 4 weeks
According to RECIST1.1, at least one measurable lesion must be present
The interval between the end of other anticancer treatments and the treatment in this study should be at least 4 weeks

Exclusion Criteria

Subjects have clinically manifested central nervous system metastases (such as brain edema, need for hormonal intervention, or progression of brain metastases). Subjects who have received previous treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 2 months, and have ceased systemic sex hormone therapy (>10mg/ day prednisone or other therapeutic hormones) for more than 2 weeks may be included
Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment
Subjects are taking immunomodulator drugs and continue to use them within 2 weeks prior to enrollment
Subjects have received MASCT or other cellular immunotherapy or PD1 antibody therapy in the previous year (subjects in the fourth group are not limited to PD1 antibody therapy)
Subject has any active autoimmune disease or a history of autoimmune disease
The subject has active tuberculosis
Subject has hepatitis C or HIV infection, or syphilis infection
If, as determined by the investigator, the subjects had other factors that could have caused the stopover, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of test data and samples
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