NCT04879043 Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
| NCT ID | NCT04879043 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Heidelberg Pharma AG |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2028-03 |
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 78 participants in total. It began in 2022-02-07 with a primary completion date of 2028-03.
⚠ 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
This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.
Eligibility Criteria
Inclusion Criteria: * Male or female aged ≥18 years. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2. * A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG). * Must have undergone SCT or is considered transplant ineligible. * Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator. * Measurable disease as per IMWG criteria. * Adequate organ system function as defined in protocol. Exclusion Criteria: * For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed. * Known central nervous system involvement. * Plasma cell leukemia. * History of congestive heart failure. * Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT. * Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion. * Radiotherapy within 21 days prior to the first study treatment infusion. * History of any other malignancy known to be active. * Known human immunodeficiency virus infection. * Patients with active infection requiring systemic anti-infective. * Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen. * Patients with positive test results for hepatitis C virus (HCV) infection. * Current active liver or biliary disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04879043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying 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 NCT04879043 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 NCT04879043 currently recruiting?
Yes, NCT04879043 is actively recruiting participants. Contact the research team at clinical@hdpharma.com for enrollment information.
Where is the NCT04879043 trial being conducted?
This trial is being conducted at Atlanta, United States, Louisville, United States, Omaha, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT04879043 clinical trial?
NCT04879043 is sponsored by Heidelberg Pharma AG. The trial plans to enroll 78 participants.