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

June 20, 2023 updated by: Lava Therapeutics

A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients With Relapsed or Refractory CLL, MM, or AML

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

An open-label, phase 1/2a dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • CHU Lille
      • Nantes, France, 44093
        • University Hospital of Nantes
  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, location AMC
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Amsterdam UMC, location VUmc
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Erasmus MC
  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
      • Madrid, Spain, 28027
        • Cima University of Navarra
      • Pamplona, Spain, 31008
        • Clinica Universida de Navarra
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Institute
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute, Atrium Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

KEY INCLUSION CRITERIA

  1. Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
  2. 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.
  3. Predicated life expectancy of ≥ 3 months.
  4. ECOG performance status of 0 or 1.

  5. Males or non-pregnant, non-breastfeeding females who are either:

    1. Surgically sterile.
    2. Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.
    3. Female, postmenopausal.
    4. Male compliant with an effective contraceptive regimen.
    5. Male refraining from donating sperm.
  6. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.

KEY EXCLUSION CRITERIA

  1. 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.
  2. 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.
  3. Uncontrolled or severe intercurrent medical condition.
  4. Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.
  5. Known ongoing drug or alcohol abuse in the opinion of the investigator.
  6. 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.
  7. Immunodeficiency disorders.
  8. Patients with Richter's transformation are excluded.

Other eligibility criteria will apply during full screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAVA-051

Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection.

  • Group A: LAVA-051
  • Group B: LAVA-051 + low dose interleukin 2

Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study
Biological: LAVA-051
In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion
Biological: Interleukin 2
In Part 1 and Part 2, a low dose of interleukin 2 will be given via subcutaneous injection with LAVA-051 in a selected group of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 & Part 2 - Frequency and severity of AEs:
Time Frame: Approximately 6 months
Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.
Approximately 6 months
Part 1 - Frequency and type of DLT
Time Frame: First 28 days of treatment
A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria
First 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 & Part 2: Number of participants with an antitumor response
Time Frame: Approximately 6 months
Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria
Approximately 6 months
Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)
Time Frame: Approximately 6 months
Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051
Approximately 6 months
Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies
Time Frame: Approximately 6 months
Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated
Approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lava Therapeutics

Investigators

  • Study Director: Clinical Trials Management, Lava Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Estimated)

September 24, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LV2020-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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