HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

Inclusion Criteria:

1. Signed Informed Consent Form (ICF)

2. Age ≥18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2

4. Relapsed/refractory patients with histologically confirmed lymphoma or cytologically confirmed CLL (flow cytometry)

5. At least one bidimensionally measurable lesion by CT with the exception of CLL, i.e., nodal lesions > 1.5 cm in maximal diameter or extranodal lesions > 1.0 cm;

6. Expected survival longer than 24 weeks

Exclusion Criteria:

Patients who met any of the following criteria are excluded from the study:

1. Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion

2. Inadequate organ function of liver and kidney

3. Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

4. Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug

5. Receipt of small molecule targeted therapy with approved anti-tumor therapy within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of study drug

6. Any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer

7. Prior use of any anti-tumor vaccine

8. Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug

9. Any uncontrolled active infection

10. History of drug-induced interstitial pneumonia