A Study of KIV-318 Injection in Patients With BCMA-Positive Relapsed/Refractory Multiple Myeloma (NCT07726160) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of KIV-318 Injection in Patients With BCMA-Positive Relapsed/Refractory Multiple Myeloma
China30 participantsStarted 2026-07-20
Plain-language summary
A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed/refractory multiple myeloma.
Who can participate
Age range
18 Years – 70 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 between 18 and 70 years (inclusive), regardless of gender;
. Diagnosis of multiple myeloma (MM) confirmed per the IMWG diagnostic criteria. and presenting with relapsed/refractory (r/r) MM following at least ≥3 prior lines of therapy. Prior therapies must have included proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and/or CD38 monoclonal antibodies. While prior exposure to all three therapeutic classes is preferred, subjects must have received at least two of these treatment categories (PIs, IMiDs, and/or anti-CD38) during their prior therapy;
. Subjects with r/r MM at screening, with documented disease progression, or who are considered refractory, either during or within 12 months after the most recent anti-myeloma treatment.
. The following cohort-specific criteria must be satisfied:
. Measurable disease at screening, meeting at least one of the following criteria:
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 , and an estimated life expectancy of ≥3 months.
. Bone marrow function test results meeting the following requirements:
. Adequate organ function, defined as:
Exclusion criteria
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 this is a Phase 1 trial focused on finding a safe dose and measuring side effects of KIV-318, what does that mean for what we'd actually know about whether it works against my myeloma at this stage?
2The trial isn't recruiting yet — given where my disease is right now, is it realistic to wait for this study to open, or should we be looking at treatments that are available sooner?
3My myeloma needs to be BCMA-positive to be considered for this trial — has my tumor been tested for BCMA expression, and what does my result mean for my options here?
4What kinds of dose-limiting toxicities or treatment-emergent side effects are doctors watching for with a BCMA-targeted injection like KIV-318, and how would those be managed if they happened to me?
5Are there already approved BCMA-targeted therapies — like a bispecific antibody or CAR-T cell therapy — that might be worth considering before or instead of enrolling in this early-phase 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 toxicity (DLT)
Timeframe: 28 days of single infusion
2
Treatment-emergent adverse events (TEAEs)
Timeframe: 2 years
Trial details
NCT IDNCT07726160
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Receipt of any type of T-cell engager (TCE) therapy within 8 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
. Receipt of any of the following within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug:
. Receipt of proteasome inhibitors, immunomodulatory agents, radiotherapy, or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
. Presence of meningeal, brainstem, or spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis.
. Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to infusion.
. Presence of active second primary malignancies, with the following exceptions: malignancies that have received curative treatment with no known active disease for ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no current evidence of disease.
. Prior treatment with any agent pseudotyped with vesicular stomatitis virus G (VSVG).
. Presence of severe, uncontrolled active infection (bacterial, viral, fungal, etc.) at screening.