Status:
UNKNOWN
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
- Recurred or did not alleviate after the previous treatment.
- Have at least one measurable lesion.
- With a life expectancy of ≥3 months.
- Male or female ≥ 18 years old.
- ECOG performance status of 0-1.
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion
- Amyloidosis, plasma cell leukemia.
- Corrected serum calcium\>3.4mmol/L(13.5mg/dl).
- Presence of metastasis to central nervous system.
- Treatment of other investigational products.
- Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
- Known history of hypersensitivity to any components of HRS-3738.
- Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05363800
Start Date
June 17 2022
End Date
December 30 2024
Last Update
July 29 2022
Active Locations (3)
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1
Henan cancer Hospital
Zhengzhou, Henan, China, 450000
2
Sheng Jing Hospital of China Medical University
Shengyang, Liaoning, China, 110004
3
Zhejiang University School of Medicine The First Affiliated Hospital
Hangzhou, Zhejiang, China, 310003