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

Lava Therapeutics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia

Treatments: Biological: Interleukin 2; Biological: LAVA-051

Study type: Interventional

Funder types: Industry

Identifiers

NCT04887259

LV2020-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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102 participants in 1 patient group

LAVA-051

Experimental group

Description:

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

Treatment:

Biological: Interleukin 2

Biological: LAVA-051