A Phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia - LAVA

AVA Therapeutics N.V.0 sites114 target enrollmentJanuary 18, 2021

ConditionsRelapsed/refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed/refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)
Sponsor: AVA Therapeutics N.V.
Enrollment: 114
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AVA Therapeutics N.V.

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 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. Patients may have undergone prior cell therapy
•2\.1\. CLL/ Small Lymphocytic Lymphoma (SLL) patients:
•2\.1\.1\. Proven disease by the presence of CD5\+CD19\+CD23\+ clonal B cells in blood, bone marrow and/or lymph nodes.
•2\.1\.2\. Patients should meet criteria for requiring therapy (the most recent iwCLL guidelines (39\)) and must have measurable disease (measurable lesion \> 1\.5 cm diameter in at least one dimension) and/or lymphocytosis
•2\.1\.3\. Patients must have received at least 2 prior lines of therapy and must have failed at least one line of targeted therapy (ibrutinib or venetoclax or similar) and not be amenable to\- or for whom no further standard treatment is available
•2\.2\. MM patients:
•2\.2\.1\. Documented diagnosis of MM and measurable disease (see Appendix 6, Section 13\.6\.2; measurable disease is defined as serum monoclonal paraprotein (M\-protein) \= 5 g/L or urine M\-protein \= 200 mg/24 hours or abnormal free light chain (FLC) ratio with involved FLC \> 100 mg/L or proven plasmacytoma by biopsy\*)
•2\.2\.2\. Documented progression or refractory multiple myeloma as per the IMWG uniform response criteria (see Appendix 6, Section 13\.6\.3\) following \=3 prior regimens that include at least one immunomodulatory drug, a proteasome inhibitor, and an anti\-CD38 monoclonal antibody in any order.
•\* If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the trial, because of difficult response evaluation.

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\. Known uncontrolled central nervous system involvement.
•5\. Patient has any active\-, uncontrolled\-, or suspected infection.
•6\. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect the patients' participation in this trial.
•7\. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or (b) uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block (will not be excluded), or (c) congestive heart failure New York Heart Association Class \= 3, or (d) myocardial infarction within 3 months or (e) QTc \> 480 msec using Fredericia’s QT correction formula.
•8\. Previous treatment with radiotherapy, targeted therapy, investigational product, or chemotherapy in the 2 weeks (or 4 weeks for previous T\-cell directed immunotherapy if requested by specific regulatory authorities) prior to initial IMP administration.
•9\. Previous treatment with an aminobisphosphonate IV (e.g., ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
•10\. Previous treatment of any systemic immunosuppressant within 2 weeks prior to initial IMP administration, with the exception of systemic corticosteroid use up to oral dose of 10 mg prednisolone daily (or equivalent for other steroids).