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

NCT04887259 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: LV2020-001
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 14

Brief 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).

Conditions

Chronic Lymphocytic Leukemia; Multiple Myeloma; Acute Myeloid Leukemia

Keywords

CLL; Phase 1 dose escalation; Phase 1 safety; Open label; MM; AML; relapsed; refractory

Outcome Measures

Primary Outcomes (2)

• 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.

  Approximately 6 months

• 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

  First 28 days of treatment

Secondary Outcomes (3)

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

  Approximately 6 months

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

  Approximately 6 months

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

  Approximately 6 months

Study Arms (1)

LAVA-051

EXPERIMENTAL

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; Biological: Interleukin 2

Interventions

LAVA-051 BIOLOGICAL

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

LAVA-051

Interleukin 2 BIOLOGICAL

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

LAVA-051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lava Therapeutics: lead

Study Sites (14)

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Levine Cancer Institute, Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

CHU Lille

Lille, 59037, France

Location

University Hospital of Nantes

Nantes, 44093, France

Location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Cima University of Navarra

Madrid, 28027, Spain

Location

Clinica Universida de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Leukemia, Myeloid, Acute; Recurrence

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Clinical Trials Management

  Lava Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 14, 2021
• Study Start: July 12, 2021
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); US (5); FR (2); ES (4)