Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.

2. Recurred or did not alleviate after the previous treatment.

3. Have at least one measurable lesion.

4. With a life expectancy of ≥3 months.

5. Male or female ≥ 18 years old.

6. ECOG performance status of 0-1.

7. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Amyloidosis, plasma cell leukemia.

2. Corrected serum calcium>3.4mmol/L(13.5mg/dl).

3. Presence of metastasis to central nervous system.

4. Treatment of other investigational products.

5. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.

6. Known history of hypersensitivity to any components of HRS-3738.

7. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.