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

Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
LV2020-001 (primary)
Study Sponsor
Lava Therapeutics


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).


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.


  1. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.