Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML LAVA-051

What's the purpose of this trial?

A phase 1/2a, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).

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.

INCLUSION CRITERIA

  • Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
  • Patients with documented diagnosis of relapsed or refractory CLL, MM, or AML who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available.
  • Predicated life expectancy of ≥ 3 months.
  • ECOG performance status of 0 or 1.
  • Males or non-pregnant, non-breastfeeding females who are:
    • Surgically sterile.
    • Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.
    • Female, postmenopausal.
    • Male compliant with an effective contraceptive regimen.
    • Male refraining from donating sperm.
  • Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.

EXCLUSION CRITERIA

  • Prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring >10 mg prednisone or equivalent corticosteroids.
  • Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. Patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. Localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed.
  • Uncontrolled or severe intercurrent medical condition.
  • Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.
  • Known ongoing drug or alcohol abuse in the opinion of the investigator.

Additional Trial Information

Phase 1/2

Enrollment: 102 patients (estimated)

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Interested in joining or learning more about this trial?

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Not Yet Accepting

New York

New York University Langone Medical Center Laura and Isaac Perlmutter Cancer Center

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Not Yet Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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