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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SYZ Cell Therapy Co..
• Collaborator: HRYZ (ShenZhen) Biotech Co.
• Treatments: Antibodies; Ifosfamide; Isophosphamide mustard

Criteria

Major Inclusion Criteria:

1. Age 18-70 at screening;

2. Obtain written informed consent of the subject/legal representative prior to conducting any program related procedures, including evaluation during the screening period;

3. Scored 0 -1 on ECOG;

4. Life expectancy ≥6 months;

5. Cardiopulmonary function is basically normal;

6. 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，(except patients with urothelial carcinoma,Serum urea nitrogen and creatinine ≤ 2.5×ULN), Serum albumin ≥30g/L

For the first group of subjects, the following criteria should be met:

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;

For the second group of subjects, the following criteria should be met:

1. 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;

2. 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.

3. 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:

1. Urothelial carcinoma: histologically or cytologically confirmed disease progression after advanced recurrence or metastasis following gemcitabine + platinum regimen first-line chemotherapy;

2. 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.

3. Cholangiocarcinoma: histologically or cytologically confirmed, progression after first-line treatment after advanced recurrence or metastasis;

4. According to RECIST1.1, at least one measurable lesion must be present;

5. 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:

1. Solid tumor with advanced recurrence or metastasis;

2. 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;

3. According to RECIST1.1, at least one measurable lesion must be present;

4. The interval between the end of other anticancer treatments and the treatment in this study should be at least 4 weeks;

Major Exclusion Criteria:

1. 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;

2. 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;

3. Subjects are taking immunomodulator drugs and continue to use them within 2 weeks prior to enrollment;

4. 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);

5. Subject has any active autoimmune disease or a history of autoimmune disease;

6. The subject has active tuberculosis;

7. Subject has hepatitis C or HIV infection, or syphilis infection;

8. 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;