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NCT Number: NCT07658352

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

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.

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Key information

Conditions

B-Cell Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Prior use of a BTK protein degrader.

Treatment and study plan

HP-002

Drug

HP-002 will be taken once daily, at approximately the same time each morning.

Primary outcomes

  1. Dose-limiting toxicities (DLTs)

    Time frame: 28 days after the first dose

  2. Adverse events (AEs)

    Time frame: up to 5 years

  3. Overall Response Rate (ORR)

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yunju Yi

CONTACT

[email protected]

+86 ext. +8613518115493

Sponsors and collaborators

Lead sponsor

Shanghai Helioson Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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