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Relapsed or Refractory AML and Other Hematologic MalignanciesPhase 1NCT06812104

Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.

A Phase 1 study testing KK2845_1, KK2845_2 and KK2845_3 in people with Relapsed or Refractory AML and Other Hematologic Malignancies, run by Kyowa Kirin Co., Ltd. at 17 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill). For patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies, in Part 1, the tolerability of KK2845 will be evaluated to determine the maximum… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KK2845_1, KK2845_2 and KK2845_3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
17 sitesJapan
Study dates
10 Oct 2024to 30 Nov 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 【Patients with Relapsed or Refractory Acute Myeloid Leukemia】
  • Patients with a confirmed diagnosis of AML according to the WHO classification (2022 edition)by pathological examination at the performing institution conducted as screening test.
  • Patients who meet the following definition of relapsed or refractory.
  • Relapse: Patients with any of the following relapse findings after achieving CR, CRh, or CRi.
  • Myeloblasts >5%
  • Blood blasts reappear in two peripheral blood samples at least one week apart
Show all 27Show fewer
  • Refractory: Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intense chemotherapy or initial treatment with venetoclax or hypomethylating agent.
  • Patients who are considered to have no standard treatment with sustained remission, who have failed to complete a potentially curative treatment, who have no treatment with a promising therapeutic effect, or who have refused standard treatment.
  • 【Patients with other Hematologic Malignancies】 1. Patients diagnosed with each type of Hematologic Malignancies.
  • 【Other criteria common to all eligible patients】
  • Patients who have given their free and voluntary written consent to participate in this clinical trial.
  • Patients must be at least 18 years of age at the time consent is obtained.
  • Patients with an ECOG PS of 0 to 2 on screening test.
  • Patients with hematopoietic, hepatic, renal, and cardiac function that meet all of the following criteria on screening test.
  • Hematopoietic capacity
  • Neutrophil count greater than 500/mm3 However, even if the neutrophil count is less than 500/mm3, if the principal investigator or sub investigator judges that the neutrophil count is expected to improve, enrollment in this study is acceptable.
  • Liver function
  • AST within 3.0 times the upper reference limit
  • ALT within 3.0 times the upper reference limit
  • T-Bil within 1.5 times the upper limit of the standard
  • Kidney function
  • Creatinine clearance (Cockcroft-gault formula) equal to or greater than 50 mL/min
  • However, even if the creatinine clearance calculated using the above formula is less than 50 mL/min, if the value is equal to or greater than 30 mL/min and the serum creatinine level is within 1.5 times the upper limit of the standard value, enrollment in this study is acceptable
  • ・Cardiac function
  • LVEF of 50% or more (MUGA or ECHO)
  • QTcF < 450 msec for males and < 480 msec for females
  • Patients who are expected to survive longer than 3 months.

Who cannot join

  • Patients who are diagnosed with APL.
  • Patients with suspected extramedullary disease.
  • Patients with a history of malignancy other than those listed in the inclusion criteria or with active malignancy other than those listed in the inclusion criteria (resected localized basal cell carcinoma and localized squamous cell carcinoma of the skin, resected noninvasive cervical cancer, resected noninvasive breast cancer, and cancers for which the last curative treatment was given more than 5 years ago are eligible for enrollment).
  • Patients with white blood cell count greater than 25000/mm3 (If treatment with hydroxyurea results in a white blood cell count of 25000/mm3 or less, enrollment in this study is acceptable) on screening test.
  • 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:
Show all 37Show fewer
  • 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. Acute GvHD is classified according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD is classified according to the NIH criteria (Jagasia et al., 2015), by Grade or severity. Acute GvHD should be graded according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD according to the NIH criteria (Jagasia et al., 2015).
  • At least 4 weeks have elapsed since the donor lymphocyte infusion at Cycle 1 Day 1.
  • Patients who have received anti-tumor therapy such as anticancer agents or radiotherapy (except for patients taking hormone therapy as adjuvant maintenance therapy for breast or prostate cancer prior to the start of study treatment) within the following time periods prior to Cycle 1 Day 1.
  • anticancer agents: 2 weeks (If hydroxyurea is used to control blasts, registration is acceptable for use up to Day -1)
  • Hormone therapy: 2 weeks
  • Radiation therapy: 4 weeks
  • Unapproved medical devices: 4 weeks
  • Patients who received another investigational drug within 4 weeks or 5 times the half-life prior to Cycle 1 Day 1, whichever is shorter.
  • Patients who underwent major surgery (excluding biopsy, central venous catheter insertion, and tooth extractions, etc.) within 4 weeks prior to Cycle 1 Day 1.
  • Patients who received a live vaccine within 4 weeks prior to Cycle 1 Day 1.
  • Patients who have not recovered to Grade 1 or below from an adverse event caused by previously administered anti-tumor therapy.
  • However, patients with alopecia or laboratory abnormalities within the range described in the selection criteria or patients experiencing Grade 2 chronic adverse events may be enrolled in this study if the investigator or subinvestigator determines that the safety evaluation of the subject will not be affected.
  • Patients with the following infections.
  • Required systemic treatment (including bacterial, viral, and fungal pathogens)
  • Difficulty for initiating anti-tumor therapy However, patients with infections controlled by antibiotic or antiviral therapy, or patients receiving prophylactic antibiotic or antiviral therapy, may be enrolled in this study.
  • Patients who are suspected SARS-CoV-2 infection (e.g., patients with mild infectious findings and a positive SARS-CoV-2 test without subsequent documentation of a negative test result, patients suspected of ongoing infection based on clinical characteristics).
  • Patients with active interstitial lung disease (including drug-induced pneumonia) or a history of such disease.
  • Patients who have received continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs within 4 weeks prior to Cycle 1 Day 1.
  • However, topical, inhalation use, and low-dose corticosteroids (equivalent to 10 mg/day of prednisolone) is acceptable for enrollment in this study.
  • Patients with a history of clinically severe cardiovascular disease (e.g., complete left bundle branch block, uncontrolled ventricular fibrillation, uncontrolled ventricular arrhythmia, angina pectoris, myocardial infarction, prolonged QT syndrome, NYHA grade III or IV congestive heart failure) within 6 months prior to screening test.
  • Patients with a history of arterial thrombosis (e.g., stroke, pulmonary embolism) within 6 months prior to the screening test.
  • Patients with positive for HBV antigen or antibody, HCV antibody, HIV antibody, or HTLV-1 antibody at screening test. However, the following cases are acceptable for enrollment in this clinical trial.
  • HBV test at screening test is negative for HBs antigen and positive for either HBc or HBs antibody or both, but HBV-DNA test is below the lower limit of quantification or below 20 IU/mL (1.3 LogIU/mL).
  • Clear history of hepatitis B vaccination and positive HBs antibody alone.
  • Negative HCV nucleic acid amplification test (HCV-RNA test) with positive HCV antibody test at screening test.
  • Patients with acquired, unclassifiable or hereditary, primary, or secondary immunodeficiency.
  • Patients with a history of Grade 3 or higher allergic reactions to antibody drugs, payloads, or excipients to KK2845.
  • Patients who are pregnant, lactating (excluded from this study even if lactation is interrupted), potentially pregnant, or wishing to become pregnant during this study period.
  • Patients with psychiatric disorders, central nervous system illnesses (e.g., encephalopathy), or social conditions that are judged to make compliance with the clinical trial difficult or affect obtaining written consent.
  • Other patients who are considered to be undesirable to participate in this study by investigator or subinvestigator.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Masayoshi Noshiro contact

+81-90-2488-4889

masayoshi.noshiro.kj@kyowakirin.com

17 sites in 1 country

Japan17 sites, 17 recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • Kameda General Hospital

    Kamogawa, Chiba, 296-8602

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920-8641

    Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

    Recruiting

  • Dokkyo Medical University Hospital

    Mibu, Tochigi, 321-0207

    Recruiting

  • Japanese Red Cross Musashino Hospital

    Musashino, Tokyo, 180-8610

    Recruiting

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8104

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Recruiting

  • Kindai University Hospital

    Osaka, 589-8511

    Recruiting

  • Saitama Medical University Hospital

    Saitama, 350-0495

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Toranomon Hospital

    Tokyo, 105-8470

    Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431

    Recruiting

  • Nippon Medical School Hospital

    Tokyo, 113-8603

    Recruiting

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

    Recruiting

Other trials in Japan

About this study

Official title: A Phase I, Multicenter, Non-controlled, Open-label, Non-randomized, Dose-escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.

This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill).

For patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies, in Part 1, the tolerability of KK2845 will be evaluated to determine the maximum tolerated dose (MTD). In Part 2, additional data will be collected by administering KK2845 at dose levels for which tolerability has been confirmed.

Being tested
KK2845_1, KK2845_2, KK2845_3, KK2845_4, KK2845_5
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KK2845_1Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_2Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_3Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_4Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_5Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_6Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_7Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_8Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_alternative_1Drug

    KK2845 will be administered at several dose levels to collect additional data.

  • KK2845_alternative_2Drug

    KK2845 will be administered at several dose levels to collect additional data.

Study groups in NCT06812104
Study groupRoleWhat they receive
KK2845 to R/R AML_1ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_1
KK2845 to R/R AML_2ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_2
KK2845 to R/R AML_3ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_3
KK2845 to R/R AML_4ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_4
KK2845 to R/R AML_5ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_5
KK2845 to R/R AML_6ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_6
KK2845 to R/R AML_7ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_7
KK2845 to R/R AML_8ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_8
KK2845 to R/R AML_alternative_1ExperimentalKK2845 will be administered at several dose levels to collect additional data.
Receives: Drug: KK2845_alternative_1
KK2845 to R/R AML_alternative_2ExperimentalKK2845 will be administered at several dose levels to collect additional data.
Receives: Drug: KK2845_alternative_2
KK2845 to other Hematologic Malignancies_1ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_1
KK2845 to other Hematologic Malignancies_2ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_2
KK2845 to other Hematologic Malignancies_3ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_3
KK2845 to other Hematologic Malignancies_4ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_4
KK2845 to other Hematologic Malignancies_5ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_5
KK2845 to other Hematologic Malignancies_6ExperimentalKK2845 will be administered at several dose levels to determine MTD.
Receives: Drug: KK2845_6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (Part 1：Dose escalation)

    Measured: At the end of Cycle 1 (each cycle is 21 or 28 days)

Secondary outcomes (8)

  1. Number of Adverse Events

    Measured: Through study completion, an average of 1 year

  2. Blood Drug Concentration

    Measured: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 21 or 28 days)

  3. Number of ADA (anti-KK2845 antibody) positive Participants

    Measured: Through study completion, an average of 1 year

  4. Best overall response (CR, CRh, CRi, MLFS, PR, Not evaluable, Relapsed disease, ORR)

    Measured: Pre-dose for Cycle 1 Day1, Each end of the cycles (each cycle is 21 or 28 days), Inspection at Discontinuation

  5. Duration of remission

    Measured: Through study completion, an average of 1 year

  6. Event-free survival

    Measured: Through study completion, an average of 1 year

  7. Time to remission

    Measured: Through study completion, an average of 1 year

  8. Overall Survival

    Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start10 Oct 2024
  3. Primary completion30 Nov 2031 (estimated)
  4. Study completion30 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812104
Sponsor's protocol ID
2845-001
Status last verified
Jun 2026
First submitted
23 Dec 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KK2845_1, KK2845_2 and KK2845_3 in people with Relapsed or Refractory AML and Other Hematologic Malignancies, run by Kyowa Kirin Co., Ltd. at 17 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Masayoshi Noshiro (+81-90-2488-4889, masayoshi.noshiro.kj@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (Part 1：Dose escalation) (time frame: At the end of Cycle 1 (each cycle is 21 or 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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