NL-OMON51940
Recruiting
Not Applicable
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-051
AVA Therapeutics BV0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- leukemia
- Sponsor
- AVA Therapeutics BV
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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.
Outcomes
Primary Outcomes
Not specified
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