Status:
TERMINATED
Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML
Lead Sponsor:
Lava Therapeutics
Conditions:
Chronic Lymphocytic Leukemia
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A phase 1, 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 ...
Detailed Description
An open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumo...
Eligibility Criteria
Inclusion
- KEY 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 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.
- Predicated life expectancy of ≥ 3 months.
- ECOG performance status of 0 or 1.
- Males or non-pregnant, non-breastfeeding females who are either:
- 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.
- KEY 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.
- 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.
- Immunodeficiency disorders.
- Patients with Richter's transformation are excluded.
- Other eligibility criteria will apply during full screening.
Exclusion
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04887259
Start Date
July 12 2021
End Date
September 6 2023
Last Update
January 27 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
NYU Langone Health
New York, New York, United States, 10016
3
Levine Cancer Institute, Atrium Health
Charlotte, North Carolina, United States, 28204
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195