OncoMatch/Clinical Trials/NCT06812104
Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Is NCT06812104 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for relapsed or refractory acute myeloid leukemia.
Treatment: KK2845_1 · KK2845_2 · KK2845_3 · KK2845_4 · KK2845_5 · KK2845_6 — This is the first in human study of KK2845. This trial consists of Part 1 (Dose escalation) and Part 2 (Backfill). In Part 1, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2845 in patients with relapsed or refractory acute myeloid leukemia. Part 2 will collect additional data at tolerated doses of KK2845.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive chemotherapy — initial
Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intensive chemotherapy or initial treatment with venetoclax or hypomethylating agents.
Must have received: venetoclax (venetoclax) — initial
Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intensive chemotherapy or initial treatment with venetoclax or hypomethylating agents.
Must have received: hypomethylating agent — initial
Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intensive chemotherapy or initial treatment with venetoclax or hypomethylating agents.
Cannot have received: allogeneic hematopoietic stem cell transplant
Exception: Allowed if ≥6 months since transplant, no active acute GvHD grade 2+ or active chronic GvHD, and ≥4 weeks since donor lymphocyte infusion
Patients who underwent a previous allogeneic hematopoietic stem cell transplant. However, enrollment in this trial is permitted if all of the following criteria are met: At least 6 months have elapsed since allogeneic hematopoietic stem cell transplantation as of Cycle 1 Day 1. The patient does not have active acute GvHD of Grade 2 or higher, nor active chronic GvHD of any severity. At least 4 weeks have elapsed since the donor lymphocyte infusion at Cycle 1 Day 1.
Lab requirements
Blood counts
Neutrophil count > 500/mm3 (enrollment allowed if expected to improve per investigator)
Kidney function
Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault); if 30–49 mL/min and serum creatinine ≤ 1.5x upper limit of standard, enrollment allowed
Liver function
AST and ALT ≤ 3.0x upper reference limit; T-Bil ≤ 1.5x upper limit of standard
Cardiac function
LVEF ≥ 50% (MUGA or ECHO); QTcF < 450 msec (males), < 480 msec (females)
Patients with hematopoietic, hepatic, renal, and cardiac function that meet all of the following criteria on screening test.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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