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Multiple Myeloma (MM)Early Phase 1NCT07628595

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

A Early Phase 1 study testing RN9101 injection in people with Multiple Myeloma (MM), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma (MM)
What is being tested?
RN9101 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
1 Jul 2026to 1 Nov 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • Pulmonary function during screening or within 2 months prior to screening meeting the following conditions:
  • Oxygen saturation ≥ 90%;
  • No clinically significant pleural effusion;
  • For females of childbearing potential, a negative pregnancy test at screening and prior to dosing, and not currently breastfeeding;
  • Males and females of childbearing potential must agree to use effective contraception from the date of informed consent signing until 1 year after the end of study treatment;
  • Males and females of childbearing potential must agree not to donate gametes (including sperm or ova) from the date of informed consent signing until 1 year after the end of study treatment;
  • The subject or their legally authorized representative has signed the Informed Consent Form (ICF), indicating understanding of the study objectives and procedures, and voluntary participation in this study.

Who cannot join

  • 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;
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  • 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;
  • Known severe allergic reaction to tocilizumab;
  • Patients unsuitable for intravenous infusion;
  • Other conditions deemed by the investigator as rendering the subject unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Fan contact

086+025-68306124

fanlei@jsph.org.cn

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Lei Fan, 086+025-68306124, fanlei@jsph.org.cn

Other trials in China

About this study

Official title: A Phase 1 Clinical Study Evaluating the Safety and Efficacy of RN9101 in the Treatment of Relapsed/Refractory Multiple Myeloma

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.

Read the detailed description

This investigator-initiated clinical study aims to evaluate RN9101, the third-generation self-inactivating lentiviral vector that carries a CD19/BCMA-targeted CAR, in patients with relapsed refractory multiple myeloma (MM). Eligible patients with multiple myeloma, who failed prior lines of therapy or show persistent minimal residual disease (MRD), will be enrolled. Participants will receive a single intravenous infusion of RN9101. Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of in vivo CAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of in vivo CAR-T in multiple myeloma.

Being tested
RN9101 injection
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RN9101 injectionDrug

    Patients will receive a single intravenous infusion of RN9101 injection

Study groups in NCT07628595
Study groupRoleWhat they receive
RN9101 injectionExperimentalRN9101 injection is a third-generation, non-replicative, self-inactivating lentivirus vector, which carries a CD19/BCMA-targeted CAR
Receives: Drug: RN9101 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs)

    Dose limiting toxicity will be assessed after injection

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

  2. Cytokine release syndrome (CRS)

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

    Measured: up to Day 28 post-infusion

  3. 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.

    Measured: up to Day 28 post-infusion

  4. Treatment-associated adverse effects (AEs)

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

    Measured: up to 1 year post-infusion

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    The responses will be assessed by IWG criteria

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

  2. Disease control rate (DCR)

    The responses will be assessed by IWG criteria

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

  3. Pharmacokinetic (PK) of RN9101

    CAR-T kinetics would be detected by flow cytometry and digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells.

    Measured: 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

  4. Pharmacodynamic (PD) of RN9101

    Levels of B cells in peripheral blood as cells/ul.

    Measured: 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

  5. Pharmacodynamic (PD) of RN9101

    Levels of serum immunoglobulins in peripheral blood as g/L.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628595
Sponsor's protocol ID
VIVO-RN9101-02
Status last verified
May 2026
First submitted
1 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RN9101 injection in people with Multiple Myeloma (MM), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Fan (086+025-68306124, fanlei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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