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Cytokine

LAVA-051 for Chronic Lymphocytic Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Lava Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0 or 1.
Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat cancer in humans. The drug will be given to patients who have not responded to other treatments.

Who is the study for?
This trial is for adults over 18 with certain blood cancers (CLL, MM, or AML) that have come back or didn't respond to treatment. They should not be eligible for standard treatments and must have a life expectancy of at least 3 months. Participants need to be physically capable (ECOG status 0-1), able to consent, and use effective birth control if necessary. Those with recent other cancer treatments or severe health issues can't join.Check my eligibility
What is being tested?
The trial is testing LAVA-051 in combination with Interleukin 2 on patients who have relapsed/refractory CLL, MM, or AML. It's the first time this drug combo is being used in humans (phase 1/2a), focusing on how safe it is and what side effects might occur.See study design
What are the potential side effects?
While specific side effects aren't listed here, phase 1/2a trials like this one are designed to identify any potential adverse reactions from new drugs such as LAVA-051 when combined with Interleukin 2.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My CLL, MM, or AML cancer has not improved or has returned after treatment, and standard treatments are not suitable for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 & Part 2 - Frequency and severity of AEs
Part 1 - Frequency and type of DLT
Secondary outcome measures
Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies
Part 1 & Part 2: Number of participants with an antitumor response
Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03007238
30%
Anemia
20%
Sepsis
20%
Hypertension
20%
Hypophosphatemia
20%
Hyperglycemia
20%
Dyspnea
10%
Bronchial infection
10%
Pneumonitis
10%
Hypotension
10%
Catheter related infection
10%
Hypokalemia
10%
Headache
10%
Anal pain
10%
Anorexia
10%
Oral pain
10%
CD4 lymphocytes decreased
10%
Alanine aminotransferase increased
10%
Lymphocyte count decreased
10%
Nausea
10%
Non-cardiac chest pain
10%
Hypercalcemia
10%
Vascular access complication
10%
Adult respiratory distress syndrome
10%
Atrial flutter
10%
Platelet count decreased
10%
Hyponatremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: LAVA-051Experimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin 2
2014
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

Lava TherapeuticsLead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
Benjamin Winograd, MD, PhDStudy ChairLava Therapeutics
Clinical Trials ManagementStudy DirectorLava Therapeutics
4 Previous Clinical Trials
501 Total Patients Enrolled

Media Library

Interleukin 2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04887259 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: LAVA-051
Chronic Lymphocytic Leukemia Clinical Trial 2023: Interleukin 2 Highlights & Side Effects. Trial Name: NCT04887259 — Phase 1 & 2
Interleukin 2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887259 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different hospitals is this study being run today?

"This clinical trial is being conducted at the Levine Cancer Institute, Atrium Health in Charlotte, North carolina; Winship Cancer Institute in Atlanta, Georgia; MD Anderson Cancer Center in Houston, Texas; as well as 4 other locations."

Answered by AI

Are we still enrolling patients in this research project?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently recruiting patients. This trial was initially posted on July 12th, 2021 and edited most recently on July 21st, 2022. The 102 participants will be drawn from 4 locations."

Answered by AI

What is the main goal of this research?

"The sponsor for this study, Lava Therapeutics, has stated that the primary objective of the study will be to measure safety and frequency of adverse events over a 6 month period. This will be done by using CTCAE version 5.0 and ASTCT grading for CRS. Additionally, the study will assess secondary outcomes including pharmacokinetics of LAVA-051 and binding of LAVA-051 to CD1d positive tumor cells."

Answered by AI

How many test subjects are needed for this research?

"That is accurate. The clinicaltrial.gov website has the latest information on this study, which was created on 7/12/2021 and updated as recently as 7/21/202. There are 4 different recruiting sites for this 102-person trial"

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML
2021. "Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887259.
~11 spots leftby Sep 2024
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