Phase 1 Myeloma Trial, Recruiting NCT06433947 Sponsor: Opna Bio LLC Condition: Myeloma
Back to Myeloma

Phase 1 Myeloma Trial, Recruiting

NCT06433947
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a confirmed diagnosis of multiple myeloma.
  • People whose multiple myeloma has come back or stopped responding to 3 or more previous treatments, where those treatments included at least one drug from each of these three groups: immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibody therapies — and for whom other standard treatments are not suitable or have caused intolerable side effects.
  • People whose blood counts, kidney function, liver function, and heart function are at adequate levels as determined by the trial site.

Who may not be able to join:

  • People who have been diagnosed with a related but different condition, such as MGUS (monoclonal gammopathy of undetermined significance), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma.
  • People who have active plasma cell leukemia (a more aggressive form of blood cancer related to myeloma).
  • People who have a rare condition called POEMS syndrome, which involves nerve damage, enlarged organs, hormone problems, and skin changes alongside abnormal proteins in the blood.
  • People who have previously experienced Stevens-Johnson syndrome (a serious skin and mucous membrane reaction).
  • People who have had localised radiation therapy to a disease site within the 2 weeks before the first dose of the study drug.
  • People who had their own stem cells or bone marrow transplanted back into them (autologous transplant) less than 90 days before the first dose of the study drug.
  • People who received a stem cell or solid organ transplant from a donor (allogeneic transplant) within the past 12 months, or who are currently taking medications to suppress the immune system due to graft-versus-host disease.
  • People who have received chemotherapy, targeted cancer therapy, or radiation therapy within the 2 weeks before the first dose of the study drug.
  • People currently taking high-dose corticosteroids (steroid medications), unless those steroids are being taken for a condition unrelated to myeloma.
  • People whose multiple myeloma has spread to the central nervous system (the brain or spinal cord).
  • People who have another active cancer, with certain exceptions — including adequately treated skin cancers or early-stage cervical cancer; a Stage 1 cancer that has been in full remission for 2 or more years; low-risk prostate cancer meeting specific criteria (confirm with trial site); or any other cancer from which the person has been cancer-free for 3 or more years.
  • People who have an active serious infection that requires intravenous (IV) antibiotic or antifungal treatment.
  • People whose Type 2 diabetes is poorly controlled.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Opna Bio LLC
Registry
ClinicalTrials.gov
Start date
22 August 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number and type of dose-limiting toxicities (DLTs); Number and type of treatment-emergent adverse events (TEAEs); Number of Participants With Clinical Laboratory Test Abnormalities

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov