A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Starting soon · Phase 1/Phase 2

Conditions studied: B-Cell Non-Hodgkin Lymphoma

In brief

This is an open-label, first-in-human dose escalation and dose expansion Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HP-002 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma This study consists of two phases: a dose-exploration phase and a dose-expansion phase. The safety and tolerability of HP-002 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined. The efficacy of HP-002 will be evaluated in Phase 2 study.

Key facts

Study ID

NCT07658352

Run by

Shanghai Helioson Pharmaceutical Co., Ltd.

People needed

114

Starts

2026-06-26

Expected to finish

2031-06-26

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
• Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL/SLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).

You may not qualify if…

• Prior use of a BTK protein degrader.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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