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

June 16, 2026 updated by: Shanghai Helioson Pharmaceutical Co., Ltd.

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: escalation part
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.
Experimental: expansion cohort 1
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.
Experimental: expansion cohort 2
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.
Experimental: expansion cohort 3
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.
Experimental: expansion cohort 4
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.
Experimental: expansion cohort 5
Drug: HP-002
HP-002 will be taken once daily, at approximately the same time each morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 28 days after the first dose
28 days after the first dose
Adverse events (AEs)
Time Frame: up to 5 years
up to 5 years
Overall Response Rate (ORR)
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Helioson Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 26, 2026

Primary Completion (Estimated)

June 26, 2029

Study Completion (Estimated)

June 26, 2031

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-002-I/II-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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