Safety and Efficacy of RN9101 in the Treatment of Relapsed/Refractory Multiple Myeloma

Starting soon · Early Phase 1

Conditions studied: Multiple Myeloma (MM)

In brief

This is a single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RN9101 injection for patients with relapsed/refractory multiple myeloma.

Key facts

Study ID

NCT07628595

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

19

Starts

2026-07-01

Expected to finish

2028-11-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be enrolled in this study:
• Age ≥18 years, either sex;
• Diagnosis of multiple myeloma (MM) according to IMWG response criteria, with BCMA target antigen expression on MM cells confirmed by flow cytometry or bone marrow pathology and immunohistochemistry;
• Received at least 2 prior lines of anti-multiple myeloma therapy, with each line containing at least one complete treatment cycle, and documented disease progression during or after the most recent anti-myeloma therapy based on assessment data;
• Measurable disease at screening, defined as meeting at least one of the following criteria:
• Serum M-protein ≥ 0.5 g/dL;
• Urine M-protein level ≥ 200 mg/24 h;
• Involved serum free light chain ≥ 10 mg/dL with abnormal serum free light chain κ/λ ratio;
• Clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Definite increase in existing plasmacytomas or bone lesions (sum of the products of perpendicular diameters [SPD] of measurable lesions increased by ≥50% with an absolute increase of ≥1 cm);
• ECOG performance status of 0-2, with an estimated life expectancy of ≥3 months;
• Bone marrow function test results (at screening or within 2 months prior to screening) meeting the following conditions:
• Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week prior to screening), with recombinant human erythropoietin permitted; for patients meeting the hemoglobin ≥ 6 g/dL enrollment criterion, red blood cell transfusions may be allowed to maintain hemoglobin ≥ 6 g/dL;
• Absolute neutrophil count (ANC) ≥ 600/μL (no granulocyte colony-stimulating factor [G-CSF] used within 1 week prior to screening, or no pegylated G-CSF used within 2 weeks prior to screening);
• Platelet count ≥ 50,000/μL;
• Lymphocyte count ≥ 500/μL;
• Absolute CD3-positive T-cell count ≥ 150/μL;
• Normal renal function during screening or within 2 months prior to screening: creatinine clearance (CrCl) (calculated by the Cockcroft-Gault formula) ≥ 45 mL/min;
• Hepatic function during screening or within 2 months prior to screening meeting the following conditions:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN);
• Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin may be ≤ 1.5 × ULN);
• Albumin ≥ 3 g/dL;
• Cardiac function during screening or within 2 months prior to screening meeting the following conditions:
• Left ventricular ejection fraction (LVEF) ≥ 40% (assessed by echocardiography or MUGA scan);
• No clinically significant pericardial effusion;
• No clinically significant electrocardiogram abnormalities;

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Received other anti-tumor therapy during the screening period (as determined primarily by the investigator):
• Received targeted therapy, epigenetic therapy, other investigational drug therapy, or treatment involving invasive investigational medical devices within 5 half-lives;
• Received systemic immunologic or non-immunologic therapy within 1 week;
• Received cytotoxic therapy within 1 week;
• Received proteasome inhibitor and immunomodulatory therapy within 2 weeks;
• Received radiotherapy within 4 weeks (except if the radiation field involves ≤5% of bone marrow reserve, in which case there is no restriction on the time since completion of radiotherapy, and the subject may still be enrolled);
• Received allogeneic hematopoietic stem cell transplantation within 6 months prior to dosing, or autologous hematopoietic stem cell transplantation within 3 months prior to dosing;
• History of malignancy other than multiple myeloma prior to screening, except for the following: malignancies treated with curative intent and with no known active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease;
• Previously received any therapy utilizing vesicular stomatitis virus glycoprotein (VSV-G) pseudotyped virus;
• Presence of severe and uncontrolled infection during screening (including bacterial, viral, fungal, etc.);
• Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range detected within 6 months prior to infusion; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test;
• Symptomatic heart failure or other cardiac diseases, such as severe arrhythmias:
• New York Heart Association (NYHA) Class III or IV congestive heart failure;
• Myocardial infarction within 6 months prior to informed consent signing, or prior coronary artery bypass grafting (CABG) or coronary artery stent implantation;
• Clinically significant ventricular arrhythmias or history of unexplained syncope (excluding vasovagal or dehydration-induced syncope);
• History of severe non-ischemic cardiomyopathy;
• Other clinically significant diseases, including:
• Primary immunodeficiency;
• Stroke or seizure within 6 months prior to screening;
• Definite clinical evidence of dementia or altered mental status;
• Parkinson's disease, parkinsonian movement disorders, or relevant history;
• Received surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after dosing (except for local anesthesia procedures);
• Received live attenuated vaccines within 1 month prior to dosing;
• Known severe allergic reaction to RN9101 or any of its formulation components;

Where it is running

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China

Full record on ClinicalTrials.gov

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