Hengrui Medicine SHR-3836 Injection Initiates Phase I Clinical Trial Indication for Multiple Myeloma

The Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase I, open-label, multicenter clinical study of SHR-3836 Injection for safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in patients with multiple myeloma conducted by Shanghai HengRui Medicine Co., Ltd. has been initiated. The clinical trial registration number is CTR20261051, and the first disclosure date is 2026-03-20.

The drug formulation is an injection. The route of administration is subcutaneous injection, and the dosing schedule is multiple administrations. The primary objective of this trial is to evaluate the maximum tolerated dose (MTD) of SHR-3836 Injection in multiple myeloma and to determine the recommended dose for Phase II clinical studies (RP2D); the secondary objectives are to evaluate its safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics, immunogenicity, and efficacy.

SHR-3836 Injection is a biologic product, indicated for multiple myeloma. Multiple myeloma is a malignant plasma cell proliferative disease, manifested by bone pain, anemia, kidney function impairment, and others. Diagnosis relies on bone marrow aspiration and immunofixation electrophoresis, and treatment is mainly based on chemotherapy and targeted therapy.

The main endpoint indicators of this trial include the SHR-3836 Injection monotherapy MTD for MM (if obtainable) and RP2D. The secondary endpoint indicators include safety endpoints (such as adverse events), PK endpoints (such as time to reach peak concentration), PD endpoints (such as sCD25 concentration), immunogenicity endpoints (anti-drug antibodies), and efficacy endpoints (such as objective response rate).

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 99 participants.

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