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OncoMatch/Clinical Trials/NCT05908409

A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies

Is NCT05908409 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies IDP-121 for multiple myeloma (mm).

Phase 1/2RecruitingIDP Discovery Pharma S.L.NCT05908409Data as of May 2026

Treatment: IDP-121The 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).

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: concomitant anti-tumor therapy

Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.

Cannot have received: allogeneic transplantation

Exception: allowed if >3 months prior and no active GVHD with immunosuppressive treatment

Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment

Lab requirements

Blood counts

Hemoglobin >8.0 g/dl (no transfusion support within 7 days); Platelets >75 x10^9/L (no transfusion support within 7 days; ≥50 x10^9/L if bone marrow infiltration); ANC >0.75 x10^9/L (no G-CSF support within 7 days)

Kidney function

Creatinine clearance >30 mL/min (Cockcroft-Gault)

Liver function

AST <2.5 x ULN (or <5 x ULN with liver metastases); ALT <2.5 x ULN (or <5 x ULN with liver metastases); total bilirubin <2 x ULN

Cardiac function

Left ventricular ejection fraction >50% or above institutional LLN by echocardiogram

Adequate hematological or biochemical parameters as specified below... Left ventricular ejection fraction >50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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