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The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients with metastatic or recurrent solid tumors who failed standard therapy.
The study is divided into two stages. The first stage is divided into two groups, both of which adopted 3+3 design. The first group is given MASCT-I by administration method 1, and the second group is given by method 2. One of the administration method will be used in the second stage according to DLT and adverse events found in the first stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MASCT-I injection | Experimental | MASCT-I injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MASCT-I injection | Biological | The final products of MASCT-I technology are dendritic cells (DC) and effector T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events related to MASCT-I | Assessed by CTCAE V5.0 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events related to MASCT-I | All adverse events and serious adverse events related to MASCT-I during the study | 2 years |
| Immune response to tumor-associated antigens |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The length of time from enrollment until the time of progression of disease | 2 years |
| Objective Response Rate (ORR) | Percentage of patients with PR and CR in the total number of patients. |
Inclusion Criteria:
1. Age ≥18 years and ≤70 years.
2. Written informed consent was obtained.
3. Pathologically confirmed solid tumors (including but not limited to soft tissue sarcoma/osteosarcoma, urothelial carcinoma, colorectal cancer), metastatic or recurrent, and failed or intolerant to standard therapy, or lack of effective treatment; Urothelial carcinoma including renal pelvic carcinoma, bladder cancer, ureteral carcinoma or urethral carcinoma.
4. ECOG performance status of 0-1.
5. Estimated life expectancy ≥ 6 months.
6. Patients must have at least one measurable lesion defined by RECIST 1.1.
7. At least 4 weeks after the end of the last anti-tumor treatment before the 1st apheresis;
8. Patients with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis) :
9. Patients with potential fertility need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; The serum or urine HCG test must be negative within 7 days before the study was included; And must be non lactating.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, Doctor | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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Measured by enzyme linked immunospot assay
| 2 years |
| Concentration of Cytokines (IFNγ、IL2、IL4、IL6、IL10 and TNF) | Measured by flow cytometry or other methods | 2 years |
| 2 years |
| Disease Control Rate (DCR) | 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 | 2 years |