OncoMatch/Clinical Trials/NCT06812104
Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Is NCT06812104 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06812104 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages