Last updated: April 5, 2022
Sponsor: Zhejiang University
Overall Status: Active - Not Recruiting
Phase
1
Condition
Lymphoproliferative Disorders
Cancer
Multiple Myeloma
Treatment
N/AClinical Study ID
NCT05325801
Sirius
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed and dated, written informed consent prior to any study specific procedures;
- Estimated life expectancy of minimum of 12 weeks;
- ECOG 0-2;
- Diagnosed as multiple myeloma according to the IMWG criteria;
- Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validatedimmunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should havemeasurable disease. At least meet one of the following criteria:
- If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum Mprotein ≥5g/L;
- urine M protein level ≥0.2g(200mg/24h);
- light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratiois abnormal;
- there are extramedullary lesions;
- Subjects have had at least 3 prior lines of therapy including chemotherapy based onproteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
- Adequate organ functions
Exclusion
Exclusion Criteria:
- Active smoldering multiple myeloma;
- Active plasma cell leukemia;
- With organ amyloidosis;
- Central nervous system (CNS) involvement;
- Pregnant or breastfeeding;
- Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positiveand detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody andhepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody
- Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg;Symptomatic heart failure per New York Heart Association Classification Class II, IIIor IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricularejection fraction (LVEF) below institution's lower limit of normal (LLN) or <50%;
- Have a history of another primary malignancy within 5 years prior to starting studytreatment. Exceptions here are as follows: the disease under study; adequately treatedbasal or squamous cell carcinoma of the skin; cancer of the cervix in situ.
Study Design
Total Participants: 9
Study Start date:
April 01, 2022
Estimated Completion Date:
March 31, 2025