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

NCT ID: NCT04887259

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-09-06

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).

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).

Conditions

Chronic Lymphocytic Leukemia; Multiple Myeloma; Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LAVA-051

Intervention Type: BIOLOGICAL

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

Interleukin 2

Intervention Type: 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

Interventions

LAVA-051

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lava Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials Management

Role: STUDY_DIRECTOR

Lava Therapeutics

Locations

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

University Hospital Vall d'Hebron

Barcelona, , Spain

Cima University of Navarra

Madrid, , Spain

Clinica Universida de Navarra

Pamplona, , Spain

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Countries

United States; France; Netherlands; Spain

Other Identifiers

LV2020-001

Identifier Type: -

Identifier Source: org_study_id