This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.
1.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
2.The expected survival time was more than 12 weeks;
3.ECOG score was 0-2;
4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;
1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
2.There was a history of other second malignancies in 5 years before screening;
3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia;
Single group
TH-CART-027
Drug3+3 dose escalation design: Dose Level 1: 0.3×10\^6 CAR+ T cells /kg; Dose Level 2: 1.0×10\^6 CAR+ T cells /kg; Dose Level 3: 3.0×10\^6 CAR+ T cells /kg
Safety：Incidence of Dose Limiting Toxicity (DLT)
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Safety：Incidence and severity of adverse events (AEs)
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
Overall survival (OS)
Time from treatment initiation to death from any cause.
Objective response rate (ORR)
The assessment will be based on the investigator's evaluation of imaging evaluations, with efficacy evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR refers to the proportion of patients with objective evidence of achieving a Complete Response (CR) or Partial Response (PR). Where applicable, responses recorded after disease progression or initiation of non-investigational anticancer therapy will be excluded.
Progression Free Survival (PFS)
Defined as the time from initiation of the investigational drug to the first occurrence of progressive disease (PD) or death from any cause in the absence of documented PD. If no tumor progression is observed and the subject does not die during the study period, the analysis cutoff date will be determined as the date of the last tumor assessment.
Disease Control Rate (DCR)
Defined as the proportion of patients achieving Partial Response (PR), Complete Response (CR), or Stable Disease (SD) according to RECIST 1.1 criteria, relative to the total number of cases in the study.
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Shanghai Tongji Hospital, Tongji University School of Medicine
Lead sponsor
ThinkingBiomed
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
