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Chronic Lymphocytic LeukemiaPhase 1NCT04887259

Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML

A Phase 1 study testing LAVA-051 and Interleukin 2 in people with Chronic Lymphocytic Leukemia and Multiple Myeloma, run by Lava Therapeutics at 14 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A phase 1, 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LAVA-051 and Interleukin 2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
14 sitesin 4 countries
Study dates
12 Jul 2021to 6 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 either:
  • Surgically sterile.
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  • 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.

Who cannot join

  • 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.
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  • Immunodeficiency disorders.
  • Patients with Richter's transformation are excluded.
  • Other eligibility criteria will apply during full screening.

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

United States5 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Levine Cancer Institute, Atrium Health

    Charlotte, North Carolina, 28204

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

Spain4 sites

  • University Hospital Vall d'Hebron

    Barcelona, 08035

  • Cima University of Navarra

    Madrid, 28027

  • Clinica Universida de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Netherlands3 sites

  • Amsterdam UMC, location VUmc

    Amsterdam, North Holland, 1081 HV

  • Amsterdam UMC, location AMC

    Amsterdam, North Holland, 1105 AZ

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

France2 sites

  • CHU Lille

    Lille, 59037

  • University Hospital of Nantes

    Nantes, 44093

Other trials in France

About this study

Official title: A Phase 1 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, 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).

Read the detailed description

An open-label, phase 1 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.

The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Being tested
LAVA-051, Interleukin 2
Keywords
CLL, Phase 1 dose escalation, Phase 1 safety, Open label, MM, AML, relapsed, refractory
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAVA-051Biological

    In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion

  • Interleukin 2Biological

    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

Study groups in NCT04887259
Study groupRoleWhat they receive
LAVA-051ExperimentalPart 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
Receives: Biological: LAVA-051; Biological: Interleukin 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 & Part 2 - Frequency and severity of AEs:

    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.

    Measured: Approximately 6 months

  2. Part 1 - Frequency and type of DLT

    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

    Measured: First 28 days of treatment

Secondary outcomes (3)

  1. Part 1 & Part 2: Number of participants with an antitumor response

    Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria

    Measured: Approximately 6 months

  2. Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051

    Measured: Approximately 6 months

  3. Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies

    Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated

    Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start12 Jul 2021
  3. Primary completion6 Sep 2023
  4. Study completion6 Sep 2023

Why it stopped: The decision to discontinue LAVA-051clinical trial follows a recent review of the competitive landscape that has continued to evolve (Business decision). The decision is not due to safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887259
Sponsor's protocol ID
LV2020-001
Status last verified
Jan 2025
First submitted
3 May 2021
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LAVA-051 and Interleukin 2 in people with Chronic Lymphocytic Leukemia and Multiple Myeloma, run by Lava Therapeutics at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Spain, Netherlands, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The decision to discontinue LAVA-051clinical trial follows a recent review of the competitive landscape that has continued to evolve (Business decision). The decision is not due to safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 & Part 2 - Frequency and severity of AEs: (time frame: Approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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