A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
Trial Parameters
Brief Summary
The main aims of this 2-part study are: * Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL). * Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years 2. Performance status (ECOG) ≤ 2 3. Life expectancy ≥3 months 4. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. 5. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 6. Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments. 7. Adequate hematological or biochemical parameters as specified below 1. Hemoglobin \> 8.0 g/dl (without transfusion support within 7 days) 2. Platelets count \> 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L. 3. Absolute neutrophil count (ANC) \> 0.75 x109/L (without G-CSF