Multiple Myeloma Clinical Trial

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

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).

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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.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA

Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
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.
Predicated life expectancy of ≥ 3 months.
ECOG performance status of 0 or 1.

Males or non-pregnant, non-breastfeeding females who are:

Surgically sterile.
Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.
Female, postmenopausal.
Male compliant with an effective contraceptive regimen.
Male refraining from donating sperm.
Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.

EXCLUSION CRITERIA

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.
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.
Uncontrolled or severe intercurrent medical condition.
Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.
Known ongoing drug or alcohol abuse in the opinion of the investigator.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT04887259

Recruitment Status:

Recruiting

Sponsor:

Lava Therapeutics

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There are 13 Locations for this study

See Locations Near You

Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Sagar Lonial, MD
Contact
[email protected]
NYU Langone Health
New York New York, 10016, United States More Info
Gareth Morgan, MD
Contact
[email protected]
Levine Cancer Institute, Atrium Health
Charlotte North Carolina, 28204, United States More Info
Peter Voorhees, MD
Contact
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Gautam Borthakur, MD
Contact
[email protected]
Spedali Civili di Brescia
Brescia , 25123, Italy More Info
Allesandra Tucci, MD
Contact
[email protected]
Universita Vita-Salute San Raffaele
Milano , 20132, Italy More Info
Paolo Ghia, MD
Contact
[email protected]
AOU Citta della Salute e della Scienza di Torino
Torino , 10126, Italy More Info
Sara Bringhen, MD
Contact
[email protected]
Amsterdam UMC, location AMC
Amsterdam Noord Holland, 1105 , Netherlands More Info
Arnon Kater, MD, PhD
Contact
[email protected]
Amsterdam UMC, location VUmc
Amsterdam Noord-Holland, 1081 , Netherlands More Info
Niels vd Donk, MD, PhD
Contact
[email protected]
Erasmus MC
Rotterdam Zuid-Holland, 3015 , Netherlands More Info
Annemiek Broijl, MD, PhD
Contact
[email protected]
University Hospital Vall d'Hebron
Barcelona , 08035, Spain More Info
Francesc Bosch, MD, PhD
Contact
[email protected]
Clinica Universida de Navarra
Pamplona , 31008, Spain More Info
Paula Rodrigues, MD
Contact
[email protected]
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain More Info
Maria Victoria Mateos, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT04887259

Recruitment Status:

Recruiting

Sponsor:


Lava Therapeutics

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