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

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ClinicalTrials.gov Identifier: NCT04887259
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Lava Therapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Multiple Myeloma Acute Myeloid Leukemia Biological: LAVA-051 Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients With Relapsed or Refractory CLL, MM, or AML
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : September 24, 2023
Estimated Study Completion Date : December 30, 2023


Arm Intervention/treatment
Experimental: LAVA-051

In part 1 (dose escalation) LAVA-051 will be administered via intravenous infusion with dose escalation

In part 2 (dose expansion) patients will receive LAVA-051 at the dose established in part 1 of the study

Biological: LAVA-051
In part 1 and part 2, LAVA-051 will be administered via intravenous infusion




Primary Outcome Measures :
  1. Part 1 & Part 2: Frequency and severity of AEs Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events [ Time Frame: Approximately 6 months ]
    Frequency, severity, and grading of Adverse Events using the CTCAE v5.0. CRS will be evaluated using the ASTCT.

  2. Part 1: Frequency and type of DLT Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events [ Time Frame: First 28 days of treatment ]
    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


Secondary Outcome Measures :
  1. Part 1 & Part 2: Number of participants with an antitumor response [ Time Frame: Approximately 6 months ]
    Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria

  2. Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC) [ Time Frame: Approximately 6 months ]
    Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051

  3. Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies [ Time Frame: Approximately 6 months ]
    Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated

  4. Part 1 & Part 2: Biomarkers, binding of LAVA-051 to Vγ9Vδ2-T cells [ Time Frame: Approximately 6 months ]
    Binding of LAVA-051 to Vγ9Vδ2-T cells will be measured in whole blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887259


Contacts
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Contact: Clinical Trials Administrator 1-800-311-6892 clinicaltrials@lavatherapeutics.com

Locations
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United States, Georgia
Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Sagar Lonial, MD       sloni01@emory.edu   
United States, New York
NYU Langone Health Not yet recruiting
New York, New York, United States, 10016
Contact: Gareth Morgan, MD       gareth.morgan@nyulangone.org   
United States, North Carolina
Levine Cancer Institute, Atrium Health Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Peter Voorhees, MD       peter.voorhees@atriumhealth.org   
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, MD       gborthak@mdanderson.org   
Italy
Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Allesandra Tucci, MD       alessandra.tucci@asst-spedalicivil.it   
Universita Vita-Salute San Raffaele Recruiting
Milano, Italy, 20132
Contact: Paolo Ghia, MD       ghia.paolo@hsr.it   
AOU Citta della Salute e della Scienza di Torino Not yet recruiting
Torino, Italy, 10126
Contact: Sara Bringhen, MD       sarabringhen@yahoo.com   
Netherlands
Amsterdam UMC, location AMC Recruiting
Amsterdam, Noord Holland, Netherlands, 1105 AZ
Contact: Arnon Kater, MD, PhD       a.p.kater@amsterdamumc.nl   
Amsterdam UMC, location VUmc Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Niels vd Donk, MD, PhD       n.vandedonk@amsterdamumc.nl   
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Contact: Annemiek Broijl, MD, PhD       a.broyl@erasmusmc.nl   
Spain
University Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Francesc Bosch, MD, PhD       fbosch@vhebron.net   
Clinica Universida de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Paula Rodrigues, MD       paurodriguez@unav.es   
Hospital Clinico Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Maria Victoria Mateos, MD       mvmateos@usal.es   
Sponsors and Collaborators
Lava Therapeutics
Investigators
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Study Director: Clinical Trials Management Lava Therapeutics
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Responsible Party: Lava Therapeutics
ClinicalTrials.gov Identifier: NCT04887259    
Other Study ID Numbers: LV2020-001
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lava Therapeutics:
CLL, MM, AML
Phase 1 dose escalation
Phase 1 safety
Phase 2 safety
Open label
Additional relevant MeSH terms:
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Leukemia
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Lymphatic Diseases
Leukemia, B-Cell