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Brief Title: Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy
Official Title: A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy
Study ID: NCT05860075
Brief Summary: This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with refractory or recurrent hematologic malignancy.
Detailed Description: IMM01 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle). The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase. Once the RP2D is determined, will explore for Classic Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma, AML, MDS and MM cohorts.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Chinese Academy of Medical Sciences and Peking Union Medical College,, Tianjin, Tianjin, China