The purpose of this study, a single-center, open, single-dose clinical study, was to evaluate the safety, tolerability, and pharmacokinetic profile of IM83 CAR-T cells in the treatment of patients with relapsed or refractory osteosarcoma
Age ≥ 16 years, both male and female;
Subjects with a diagnosis of osteosarcoma of the extremity confirmed by pathohistologic examination;
To enroll subjects with recurrent or refractory extremity osteosarcoma who have failed or are intolerant to first-line standard therapy and who are not candidates for radical surgery and/or localized therapy and who lack effective subsequent treatment.
Standard treatment failure was defined as disease relapse or progression during or within 6 months of completion of treatment with first-line chemotherapeutic agents (including high-dose methotrexate, doxorubicin, cisplatin, isocyclophosphamide, etc.);
Presence of brain metastases;
Subjects who have previously received or are awaiting an organ transplant;
Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);
Autoimmune diseases requiring systemic immunosuppressive therapy, such as systemic lupus erythematosus, rheumatoid arthritis, and ulcerative colitis, within 2 years prior to the start of screening;
Single group
IM83 CAR-T Cells
Biological/VaccineIM83 CAR-T Cells, 5×10\^8 cells, 1×10\^9 cells, and 2×10\^9 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.
Incidence of Treatment Related adverse events (AEs)
Incidence of Adverse Events and Abnormal Findings on Clinically Significant Laboratory Tests Associated with IM83 CAR-T Cell Therapy Within 28 Days of Infusion
Objective response rate (ORR)
Objective remission rate (ORR) after infusion
Disease control rate (DCR)
Post-infusion disease control rate (DCR)
Duration of response (DOR)
Duration of disease remission (DoR) after infusion
Progress free survival (PFS)
Progress free survival (PFS) after infusion
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Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead sponsor
Guangdong Provincial People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
