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

Verified

Overview

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).

SparkCures ID 1321
Trial Phase Phase 1/2
Enrollment 102 Patients
Treatments
  • LAVA-051
Tags
Trial Sponsors
  • Lava Therapeutics
NCT Identifier

NCT04887259

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.
  • Previous autologous haematopoietic stem cell transplantation (HSCT) or treatment with Chimeric Antigen Receptor (CAR) T-cell therapy within 6 months prior to initial IMP administration.
  • Immunodeficiency disorders.
  • Patients with Richter's transformation are excluded.
  • Other eligibility criteria will apply during full screening.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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