Recruiting
Phase 1
Phase 2

HDP-101

Sponsor:

Heidelberg Pharma AG

Code:

NCT04879043

Conditions

Multiple Myeloma

Plasma Cell Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HDP-101

Study Details

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.

Conditions

Multiple Myeloma

Plasma Cell Disorder

Study ID

NCT04879043

Start date

Feb 7, 2022

Status verified date

Jul, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HDP-101

Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.

During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.

Interventions

HDP-101

HDP-101 is available as lyophilized white powder for preparation of infusion.

Primary outcome measure

  • Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol [ Time Frame: Up to Day 21 (from first dose) ]
  • Objective response rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Lei Wang, MD

+ 49 6203 1009 0clinical@hdpharma.com

Locations

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Mount Sinai, The Tisch Cancer Instutute

Recruiting

New York, New York, United States, 10029

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Heidelberg Pharma AG

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Heidelberg Pharma AG on 2026-07-17.