NCT06433947 Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
| NCT ID | NCT06433947 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Opna Bio LLC |
| Condition | Relapsed Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-08-22 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2024-08-22 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma (MM) * Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit * Adequate hematologic, renal, liver, cardiac function Exclusion Criteria: * Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma * Active plasma cell leukemia * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome) * Prior Stevens Johnson syndrome * Localized radiation therapy to disease site(s) within 2 weeks of the first dose * Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug * Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded. * Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug * Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma) * Known central nervous system involvement by multiple myeloma * Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years * Ongoing systemic infection requiring parenteral treatment * Poorly controlled Type 2 diabetes
Frequently Asked Questions
Who can join the NCT06433947 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06433947 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06433947 currently recruiting?
Yes, NCT06433947 is actively recruiting participants. Visit ClinicalTrials.gov or contact Opna Bio LLC to inquire about joining.
Where is the NCT06433947 trial being conducted?
This trial is being conducted at Gilbert, United States, La Jolla, United States, Stanford, United States, Atlanta, United States and 8 additional locations.
Who is sponsoring the NCT06433947 clinical trial?
NCT06433947 is sponsored by Opna Bio LLC. The trial plans to enroll 130 participants.