Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML
18 Years and older, Male and Female
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,
- KEY INCLUSION CRITERIA
1. Patient must be 18 years of age inclusive or above at the time of signing the informed
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
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
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
7. Immunodeficiency disorders.
8. Patients with Richter's transformation are excluded.
Other eligibility criteria will apply during full screening.
Treatment Sites in Georgia
**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