Advanced Solid Tumor Clinical Trial
Official title:
A Single-Arm, Open-Label, Investigator-Initiated Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Oncolytic Virus Injection (OVV-01) in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors
This is a prospective, multi-center, open-label, single-arm, investigator-initiated clinical trial to evaluate the safety and efficacy of oncolytic virus injection (OVV-01) in combination with trained immunity NK (tiNK) cell injection (IBR900) for patients with advanced malignant tumors.
In this study, it is planned to enroll about 6-12 subjects with advanced solid tumors or relapsed/refractory lymphomas who have failed in the third-line or higher standard of care in about 1-3 study sites in China. A 2-dose gradient joint exploratory study using the traditional "3+3" mode is adopted in this study. If the high-dose group does not yet reach the MTD, the investigator and funder will decide whether to continue the dose escalation and whether to add a new dose group. 2 dose gradients are used for the OVV-01 injection, and the total infusion dose of IBR900 cell injection is 4.0×10^9 cells per cycle. OVV-01 injection will be first administered at W1D1 and then at W4D1 followed by every 2 weeks as a treatment cycle, for a total of 6 doses; after the test in the high-dose group is completed, the investigator and sponsor will determine whether to adjust the dosing frequency of OVV-01 (such as once a week) based on the result evaluations. The IBR900 cell injection will be first administered at W1D3 and W1D5 for 2 infusions, and then at W4D3 and W4D5, followed by every 4 weeks as a cycle, for a total of 4 doses, and cell infusions will be conducted at W1, W4, W8 and W12, respectively. ;
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