Relapsed or Refractory Indolent B-cell Non-Hodgkin's LymphomaPhase 1NCT03985189
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing ME-401 in people with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, run by Kyowa Kirin Co., Ltd. at 9 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- ME-401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 9 sitesJapan
- Study dates
- 29 Apr 2019to 15 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Phase 1 study (DLT evaluation)]
- Patients aged 20 years or older at the submission of the written informed consent form
- Patients with relapsed or refractory B-cell NHL
- Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.
- Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors.
- Patients with ECOG PS 0 or 1.
Who cannot join
- [Phase 1 study (DLT evaluation)]
- Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product.
- Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those.
- Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test.
- Patients with active interstitial lung disease or a history thereof.
- Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Aomori Prefectural Central Hospital
Aomori, 030-8553
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka, 812-8582
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Okayama University Hospital
Okayama, 700-8558
Hokkaido University Hospital
Sapporo, Hokkaido, 060-0814
About this study
Official title: A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information
- Being tested
- ME-401
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-401Drug
[Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability.
[Roll over study] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| ME-401 | Experimental | ME-401 administered orally Receives: Drug: ME-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to approximately 1 year
Secondary outcomes (8)
[Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)
Measured: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start29 Apr 2019
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Indolent B-cell Non-Hodgkin's LymphomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- NCT03985189
- Sponsor's protocol ID
- ME-401-K01
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goto H, Izutsu K, Ennishi D, Mishima Y, Makita S, Kato K, Hanaya M, Hirano S, Narushima K, Teshima T, Nagai H, Ishizawa K. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921. doi: 10.1007/s12185-022-03450-5. Epub 2022 Sep 15.
PubMed 36107394
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study
- ClinicalTrials.gov ID
- NCT03985189
- Acronym / sponsor ID
- ME-401-K01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 13 Jun 2019 (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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ME-401 | Experimental | Drug: ME-401ME-401 administered orally |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- [Phase 1 study (DLT evaluation)]
- Patients aged 20 years or older at the submission of the written informed consent form
- Patients with relapsed or refractory B-cell NHL
- Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.
- Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors.
Key exclusion criteria (6 listed)
- [Phase 1 study (DLT evaluation)]
- Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product.
- Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those.
- Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test.
- Patients with active interstitial lung disease or a history thereof.
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 |
|---|---|---|
| ME-401[Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability. [Roll over study] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met. | Drug | ME-401 |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 1 year
8 secondary outcomes
[Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)
Time frame: Up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 36107394Goto H, Izutsu K, Ennishi D, Mishima Y, Makita S, Kato K, Hanaya M, Hirano S, Narushima K, Teshima T, Nagai H, Ishizawa K. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921. doi: 10.1007/s12185-022-03450-5. Epub 2022 Sep 15.
- Goto H, Izutsu K, Ennishi D, et al. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ME-401 in people with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, run by Kyowa Kirin Co., Ltd. at 9 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to approximately 1 year). 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 NCT03985189, which also lists 1 linked publication.
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 19 Dec 2025.