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Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT04887259•Lava Therapeutics

View on ClinicalTrials.gov

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).

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (14)

Emory Winship Cancer Institute

Atlanta, Georgia, United States

NYU Langone Health

New York, New York, United States

Levine Cancer Institute, Atrium Health

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

CHU Lille

Lille, France

University Hospital of Nantes

Nantes, France

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

Key Dates

Start Date

July 12, 2021

Primary Completion Date

September 6, 2023

Completion Date

September 6, 2023

Last Updated

January 27, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Lymphocytic LeukemiaMultiple MyelomaAcute Myeloid Leukemia

Interventions

LAVA-051

BIOLOGICAL

Interleukin 2

BIOLOGICAL

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

View study

RECRUITINGPHASE3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

View study

RECRUITINGPHASE2

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies