A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM HPN217

What's the purpose of this trial?

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Major Inclusion Criteria:

  1. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
  2. Measurable disease defined as at least one of the following:
    1. Serum M-protein ≥0.5 g/dL
    2. Urine M-protein ≥200 mg/24 hours
    3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  4. Adequate hematologic status, including:
    1. Absolute neutrophil count (ANC) ≥1000 cells/μL
    2. Platelet count ≥50,000/μL (without transfusions)
    3. Hemoglobin ≥8 g/dL
  5. Adequate renal function, including:
    1. Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault
  6. Adequate hepatic function, including
    1. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
    2. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
    3. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

Major Exclusion Criteria:

  1. Prior exposure to BCMA-targeting agents (Part 2 only)
  2. Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening

Additional Trial Information

Phase 1

Enrollment: 70 patients (estimated)

View More

Published Results

Updated Interim Results from a Phase 1 Study of HPN217, a Half-Life Extended Tri-Specific T Cell Activating Construct (TriTAC®) Targeting B Cell Maturation Antigen (BCMA) for Relapsed/Refractory Multiple Myeloma (RRMM)

December 11, 2022

As of June 27, 2022, 49 patients were treated with HPN217. The highest fixed-dose level administered was 2860 μg/wk. The highest step-dose level assessed was 12000 μg/wk, dose escalation in step-dose regimens is ongoing. Patients received a median of 6 prior systemic regimens (84% prior transplantation, 69% penta-exposed, 22% prior BCMA-targeted therapy). Median age (range) was 70 (38-78). Median duration of treatment is 10.1 weeks (0.1 – 64 weeks; patient at 64 weeks ongoing with a continued response). The most common (≥20%) treatment-emergent adverse events (TEAEs) were anemia (49%), fatigue (37%), CRS (25%), nausea (22%), arthralgia (20%), diarrhea (20%) and transaminitis (20%). All CRS events were G1-G2 (no ≥ G3 events reported). In step-dose regimens, all CRS events were G1. No events of Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) were reported. Two dose-limiting toxicities (DLTs) of transaminitis were reported at 2860 μg/wk. No sequelae of liver failure were associated with these events. No DLTs have been reported in the step-dose regimen and the MTD has not been reached.

HPN217 continues to exhibit linear and dose proportional PK across dose levels with a median half-life of 66 h (range 26 to 197 h). Transient cytokine increases are higher with initial dosing compared to subsequent and step dosing. Patients with objectives responses (PR or better) have on treatment reduction in soluble BCMA, higher cytokine elevations and higher upregulation of the activation marker CD69 on CD8+ T cells.

Responses have been observed at all dose levels ≥ 2150 μg/wk. Dose escalation is continuing in step-dose regimens at 24000 μg/wk. Updated data including duration of response will be presented at the meeting.

Trial Links

Read the latest news and updates on this trial.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Open and Accepting

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting


Moores Cancer Center UC San Diego Health

La Jolla, CA

Open and Accepting



University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

New York

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Open and Accepting


Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting


Swedish - Cherry Hill Campus Cherry Hill Campus

Seattle, WA

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message