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

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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 r...

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 benefit?CR,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.

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