Hematologic NeoplasmsPhase 1/2NCT07629726
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
A Phase 1/2 study testing KK2430 in people with Hematologic Neoplasms, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
Trial summary
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and Drug Administration (FDA), and this is the first time it will be given to people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- KK2430
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Oct 2027
- Phase
- Phase 1/2
- 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
- Participants must be at least 18 years of age at the time of signing the informed consent.
- At least 1 measurable diseases based on CT scan or MRI
- Renal function values
- Participants who have an ECOG PS score of 0, 1 or 2.
- Be willing to provide a fresh tissue taken at current relapse at screening period.
- Meet laboratory values at Screening i.e., ANC, Platelets, Corrected serum calcium, AST and ALT, Total bilirubin etc
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- Contraceptive use by [men and women] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Women of childbearing potential and fertile men must agree to use highly effective contraceptive methods • At least 1 measurable diseases based on CT scan or MRI
- Capable of giving signed informed consent
- Health Information Access: Capable of providing access to personal health information via HIPAA authorization (US only).
- Legal Status: Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.
Who cannot join
- Medical Conditions
- History of prior allogenic transplant.
- Presence of Grade 2 peripheral neuropathy with pain.
- Impaired cardiac function or clinically significant cardiac disease at Screening
- Known active CNS involvement or clinical signs of meningeal involvement.
- Evidence of HIV infection.
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- Active chronic HBV/HCV infection,
- Participants with positive anti-HBc must have a negative HBV-DNA quantification test result to be enrolled.
- Receipt of any anti-tumor therapy within three weeks or at least five half-lives prior to the Screening visit, whichever is shorter.
- Toxicities from prior anticancer therapies that have not resolved to Grade 1 or less except for abnormal clinical values alopecia and peripheral neuropathy (participants with Grade 1 or 2 neuropathy without pain are eligible for enrollment).
- Use of systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days prior to the first dose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Dr Bhumika Patel, +1 864-455-3600, Bhumika.Patel@prismahealth.org
Janine Benedetto, Janine.Benedetto@prismahealth.org
About this study
Official title: A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and Drug Administration (FDA), and this is the first time it will be given to people. The purpose of this Study is to find out more information about KK2430, whether it is safe in humans, how the body processes it, and if it works for treating your condition.
- Conditions
- Hematologic Neoplasms
- Being tested
- KK2430
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KK2430Drug
KK2430 administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| 2430-001 Part 1 | Experimental | KK2430 intravenous administration (including placebo) Receives: Drug: KK2430 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Level Toxicity (DLT)
Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0.
Measured: Endpoint 28 days after first dose
Adverse Events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (all 72 potentially treated subjects)
Measured: Signing of ICF through study completion for an average of 1.5 years
Pregnancy Test
Presence of hCG hormone
Measured: Screening through study completion, an average of 1.5 years
ECG QT Interval
Duration in ms
Measured: Treatment period, an average of 3months
ECG QRS Interval
Duration in ms
Measured: Treatment period, an average of 3months
Vital Sign Measurements
Axillary body temperature; Degrees Celsius
Measured: Treatment period, an average of 3 months
Vital Sign Measurements
Pulse Rate; beats per minute
Measured: Treatment period, an average of 3 months
Vital Sign Measurements
Respiratory rate; breaths per minute
Measured: Treatment period, an average of 3 months
Vital Sign Measurements
Systolic/Diastolic blood pressure; mm Hg
Measured: Treatment period, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629726
- Sponsor's protocol ID
- 2430-001
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms
- ClinicalTrials.gov ID
- NCT07629726
- Acronym / sponsor ID
- 2430-001
- Conditions
- Hematologic Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and Drug Administration (FDA), and this is the first time it will be given to people. The purpose of this Study is to find out more information about KK2430, whether it is safe in humans, how the body processes it, and if it works for treating your condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2430-001 Part 1 | Experimental | Drug: KK2430KK2430 intravenous administration (including placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must be at least 18 years of age at the time of signing the informed consent.
- At least 1 measurable diseases based on CT scan or MRI
- Renal function values
- Participants who have an ECOG PS score of 0, 1 or 2.
- Be willing to provide a fresh tissue taken at current relapse at screening period.
Key exclusion criteria (11 listed)
- Medical Conditions
- History of prior allogenic transplant.
- Presence of Grade 2 peripheral neuropathy with pain.
- Impaired cardiac function or clinically significant cardiac disease at Screening
- Known active CNS involvement or clinical signs of meningeal involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KK2430KK2430 administered intravenously | Drug | 2430-001 Part 1 |
Primary outcome
Dose Level Toxicity (DLT)
Time frame: Endpoint 28 days after first dose
Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0.
Adverse Events (AEs)
Time frame: Signing of ICF through study completion for an average of 1.5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (all 72 potentially treated subjects)
Pregnancy Test
Time frame: Screening through study completion, an average of 1.5 years
Presence of hCG hormone
ECG QT Interval
Time frame: Treatment period, an average of 3months
Duration in ms
ECG QRS Interval
Time frame: Treatment period, an average of 3months
Duration in ms
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Axillary body temperature; Degrees Celsius
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Pulse Rate; beats per minute
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Respiratory rate; breaths per minute
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Systolic/Diastolic blood pressure; mm Hg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KK2430 in people with Hematologic Neoplasms, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
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 11 inclusion and 11 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kyowa Kirin, Inc. (+1-609-919-1100, KKD.Clinical.82@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Level Toxicity (DLT) (time frame: Endpoint 28 days after first dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.