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

NCT07628595 | Not Yet Recruiting Early Phase 1

• 1 other identifier: VIVO-RN9101-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicities (DLTs)

  Dose limiting toxicity will be assessed after injection

  Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.

• Cytokine release syndrome (CRS)

  Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus

  up to Day 28 post-infusion

• immune cell-associated neurotoxicity syndrome (ICANS)

  ICANS would be scored according to Immune Effector Cell-Associated Encephalopathy (ICE), and then graded by the ASTCT consensus.

  up to Day 28 post-infusion

• Treatment-associated adverse effects (AEs)

  All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  up to 1 year post-infusion

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Day 28, Month 3, Month 6 and Month 12 post-infusion

• Disease control rate (DCR)

  Day 28, Month 3, Month 6 and Month 12 post-infusion

• Pharmacokinetic (PK) of RN9101

  Baseline, Day 0, Day 1, Day 3, Day 7, Day 9, Day 12, Day 14, Day 21, Day 28, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 post-infusion

• Pharmacodynamic (PD) of RN9101

  Baseline, Day 0, Day 7, Day 14, Day 21, Day 28, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 post-infusion

• Pharmacodynamic (PD) of RN9101

  Baseline, Day 0, Day 7, Day 14, Day 21, Day 28, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 post-infusion

Study Arms (1)

RN9101 injection

EXPERIMENTAL

RN9101 injection is a third-generation, non-replicative, self-inactivating lentivirus vector, which carries a CD19/BCMA-targeted CAR

Drug: RN9101 injection

Interventions

RN9101 injection DRUG

Patients will receive a single intravenous infusion of RN9101 injection

RN9101 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Lei Fan

CONTACT

086+025-68306124; fanlei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)