Safety and Efficacy of RN9101 in the Treatment of Relapsed/Refractory Multiple Myeloma (NCT07628595) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety and Efficacy of RN9101 in the Treatment of Relapsed/Refractory Multiple Myeloma
China19 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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);
Exclusion criteria
. Received other anti-tumor therapy during the screening period (as determined primarily by the investigator):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since RN9101 is in an early Phase 1 trial that hasn't even started enrolling yet, what does that mean for how much we currently know about whether it's safe or effective for relapsed/refractory multiple myeloma?
2The trial is specifically measuring serious side effects like cytokine release syndrome and a neurological condition called ICANS — how severe can these reactions be, and how would the medical team monitor and manage them if they happened to me?
3Given that this is a dose-finding study focused primarily on safety rather than proving the treatment works, would it make more sense for me to try other approved therapies first before considering an early-phase trial like this?
4Since the trial isn't recruiting yet, do you have a sense of when it might open, and is there a way to be notified or put on a list so we don't miss the enrollment window if it does become relevant?
5Are there other trials or standard treatments for relapsed/refractory multiple myeloma that are further along in development and might offer a clearer picture of both the risks and potential benefits compared to this very early-stage study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting toxicities (DLTs)
Timeframe: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.
. 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;