Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Investigational drug(s) / intervention(s)
HRS-3738
HRS-3738: HRS-3738 will be administrated per dose level in which the patients are assigned.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maximum tolerated dose (MTD) — From Day 1 to Day 28 Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
RP2D — From Day 1 to Day 28 RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
Trial sites (3)
Facility
City
Region
Status
Henan cancer Hospital
Zhengzhou
Henan
Sheng Jing Hospital of China Medical University
Shengyang
Liaoning
Zhejiang University School of Medicine The First Affiliated Hospital
Hangzhou
Zhejiang
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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