B-cell Precursor Acute Lymphoblastic Leukemia (ALL)Phase 1NCT07854652
BEBT-908 in MEF2D-Rearranged Relapsed/Refractory or MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
A Phase 1 study testing Ifupinostat Hydrochloride in people with B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a single-center, open-label, exploratory study evaluating ifupinostat hydrochloride (BEBT-908) in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) with MEF2D rearrangement. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Ifupinostat Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Aug 2030
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntary participation in the study and provision of written informed consent. For participants aged 14-17 years, written informed consent must be provided by a legal guardian, together with the participant's assent or confirmation as required by the ethics committee.
- Age ≥14 years and ≤75 years at the time of informed consent, regardless of sex.
- Diagnosis of B-cell precursor acute lymphoblastic leukemia (BCP-ALL) based on morphology, immunophenotyping, and clinical assessment.
- Prior clinical testing suggesting MEF2D rearrangement, with confirmation of the MEF2D rearrangement and its specific fusion partner during screening by RNA sequencing or a targeted RNA fusion panel.
- Meets either of the following baseline disease-status criteria:
- Relapsed/refractory disease: relapse, refractory disease, or disease progression after at least one line of systemic anti-leukemia therapy, with evaluable bone marrow and ≥5% blasts/lymphoblasts at screening; or
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- Morphologic remission with MRD positivity: achievement of CR, CRh, or CRi after at least one course of standard induction or salvage therapy, with flow cytometry MRD ≥0.01% and/or MEF2D fusion transcript/ABL1 ≥0.1% at screening.
- Bone marrow morphology, flow cytometry MRD, and quantitative RT-qPCR for the MEF2D fusion transcript are all performed during screening and meet the applicable baseline stratification and enrollment requirements. Participants in MLFS are not eligible through the MRD-positive pathway.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Estimated life expectancy >12 weeks.
- Peripheral blood white blood cell count <25 × 10^9/L before the first dose of ifupinostat hydrochloride; cytoreduction during screening is permitted to achieve this threshold.
- Adequate organ function:
- ALT and AST ≤2.5 × ULN; values up to ≤5 × ULN may be permitted when abnormalities are attributable to leukemic hepatic involvement, prior therapy, or another controllable cause, at the investigator's discretion;
- Total bilirubin ≤1.5 × ULN; ≤3 × ULN is permitted for Gilbert syndrome;
- Creatinine clearance ≥50 mL/min;
- Left ventricular ejection fraction (LVEF) ≥45%.
- No active central nervous system leukemia on cerebrospinal fluid examination during screening.
- Prior therapy meets the protocol-specified washout requirements, and acute non-hematologic toxicities have recovered to CTCAE Grade 0-1, baseline, or a clinically stable level. Reductions in ANC, hemoglobin, or platelet count attributable to leukemia or prior therapy are not exclusionary.
- Participants of childbearing potential agree to use effective contraception during study treatment and for the protocol-specified period after the last dose.
Who cannot join
- Isolated extramedullary relapse, or active extramedullary leukemia without bone marrow disease meeting one of the protocol-defined enrollment pathways.
- Active central nervous system leukemia.
- Failure to confirm MEF2D rearrangement during screening.
- White blood cell count ≥25 × 10^9/L before the first dose despite cytoreduction, or an unacceptable risk of leukostasis, tumor lysis syndrome, severe infection, severe bleeding, or other acute complications as judged by the investigator.
- Inadequate washout from prior therapy:
- Chemotherapy, radiotherapy, immunotherapy, or other clearly anti-leukemia treatment within 14 days;
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- Small-molecule investigational or targeted therapy within 14 days or 5 half-lives, whichever is shorter;
- Large-molecule therapy within 28 days or 5 half-lives, whichever is shorter;
- CAR-T therapy or autologous transplantation within 60 days with ongoing active CRS, ICANS, or uncontrolled toxicity;
- Allogeneic transplantation within 100 days, or active graft-versus-host disease or ongoing systemic immunosuppressive therapy.
- Uncontrolled active infection, active invasive fungal infection, active tuberculosis, sepsis, or septic shock.
- Uncontrolled HBV, HCV, or HIV infection; active syphilis; or active EBV- or CMV-related organ disease.
- Screening QTcF >450 ms in males or >470 ms in females; congenital long QT syndrome; clinically significant arrhythmia; or requirement for continued use of an irreplaceable medication known to prolong the QT interval.
- Uncontrolled or clinically significant cardiovascular disease, including recent myocardial infarction, unstable angina, severe heart failure, or severe arrhythmia.
- Pregnancy or breastfeeding.
- Known hypersensitivity to ifupinostat or any component of the formulation.
- Inability to avoid strong CYP3A4 inducers, or requirement for long-term use of strong CYP3A4 inhibitors or QT-prolonging drugs that cannot be safely managed.
- Another malignancy that may interfere with assessment of efficacy or safety in this study, except for malignancies considered cured and at low risk of recurrence at the investigator's discretion.
- Psychiatric, cognitive, or compliance-related problems that prevent adequate understanding of or adherence to study requirements.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of soochow university
Suzhou, 215000
Suning Chen, MD, PhD, +86 051267972817, chensuning@suda.edu.cn
About this study
Official title: An Exploratory Clinical Study of Ifupinostat Hydrochloride for Injection (BEBT-908) Monotherapy in Relapsed/Refractory or Measurable Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia With MEF2D Rearrangement
This is a single-center, open-label, exploratory study evaluating ifupinostat hydrochloride (BEBT-908) in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) with MEF2D rearrangement. The study will include patients with relapsed or refractory disease and patients who are in morphologic remission but still have measurable residual disease (MRD).
The main purpose of the study is to evaluate the preliminary anti-leukemia activity of BEBT-908 in patients with relapsed or refractory disease and its ability to reduce or eliminate residual leukemia in patients with MRD-positive disease. The study will also assess the depth and duration of response, survival outcomes, subsequent treatment such as stem cell transplantation or CAR-T therapy, and the safety and tolerability of BEBT-908.
Approximately 10 to 15 participants aged 14 to 75 years are planned to be enrolled. All participants will receive BEBT-908 by intravenous infusion at 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to two cycles. Bone marrow morphology, flow cytometry MRD, and MEF2D fusion transcript levels will be evaluated during the study to assess treatment response.
- Being tested
- Ifupinostat Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifupinostat HydrochlorideDrug
Also called BEBT-908
Ifupinostat hydrochloride (BEBT-908) will be administered intravenously at a dose of 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to 2 cycles. Each dose will be administered as a constant-rate intravenous infusion over 30 ± 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| BEBT-908 Monotherapy | Experimental | Not described Receives: Drug: Ifupinostat Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate in Participants With Relapsed/Refractory Disease
The proportion of participants with relapsed/refractory MEF2D-rearranged BCP-ALL who achieve a best overall response of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) during the first 2 treatment cycles.
Measured: From first dose through Cycle 2 Day 21 ± 3 days (approximately 6 weeks)
Complete MRD Response Rate in Participants With MRD-Positive Disease
The proportion of participants with morphologic remission but MRD-positive MEF2D-rearranged BCP-ALL who achieve a complete MRD response, defined as flow cytometry MRD <0.01% and MEF2D fusion transcript/ABL1 <0.1% at the same assessment time point, with both measurements evaluable.
Measured: From first dose through Cycle 2 Day 21 ± 3 days
Secondary outcomes (3)
Overall Survival
Overall survival is defined as the time from the first dose of ifupinostat hydrochloride to death from any cause. Participants who remain alive will be censored at the date they were last known to be alive.
Measured: From first dose until death or last known follow-up, up to approximately 30 months
Event-Free Survival
Event-free survival (EFS) will be evaluated separately by baseline disease stratum. In the relapsed/refractory stratum, events include failure to achieve CR, CRh, CRi, or MLFS after 2 cycles, disease progression, morphologic relapse after response, initiation of new anti-leukemia therapy for insufficient efficacy, or death from any cause. In the MRD-positive stratum, events include failure to achieve complete MRD response after 2 cycles, MRD progression, morphologic relapse, initiation of new anti-leukemia therapy for insufficient efficacy, or death from any cause.
Measured: From first dose until an EFS event or last follow-up, up to approximately 30 months
Incidence of Adverse Events and Serious Adverse Events
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), Grade 3-4 AEs, and treatment-related AEs, assessed using NCI CTCAE version 5.0. Events will also be summarized by relationship to study treatment and by whether they resulted in treatment interruption, modification, or discontinuation.
Measured: From first dose through 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Precursor Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou BeBetter Med Co., Ltd
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854652
- Sponsor's protocol ID
- SZ-ALL 03
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Ifupinostat Hydrochloride for Injection (BEBT-908) Monotherapy in Relapsed/Refractory or Measurable Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia With MEF2D Rearrangement
- ClinicalTrials.gov ID
- NCT07854652
- Acronym / sponsor ID
- SZ-ALL 03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Guangzhou BeBetter Med Co., Ltd
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 2 Oct 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.
This is a single-center, open-label, exploratory study evaluating ifupinostat hydrochloride (BEBT-908) in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) with MEF2D rearrangement. The study will include patients with relapsed or refractory disease and patients who are in morphologic remission but still have measurable residual disease (MRD).
The main purpose of the study is to evaluate the preliminary anti-leukemia activity of BEBT-908 in patients with relapsed or refractory disease and its ability to reduce or eliminate residual leukemia in patients with MRD-positive disease. The study will also assess the depth and duration of response, survival outcomes, subsequent treatment such as stem cell transplantation or CAR-T therapy, and the safety and tolerability of BEBT-908.
Approximately 10 to 15 participants aged 14 to 75 years are planned to be enrolled. All participants will receive BEBT-908 by intravenous infusion at 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to two cycles. Bone marrow morphology, flow cytometry MRD, and MEF2D fusion transcript levels will be evaluated during the study to assess treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEBT-908 Monotherapy | Experimental | Drug: Ifupinostat Hydrochloride |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Voluntary participation in the study and provision of written informed consent. For participants aged 14-17 years, written informed consent must be provided by a legal guardian, together with the participant's assent or confirmation as required by the ethics committee.
- Age ≥14 years and ≤75 years at the time of informed consent, regardless of sex.
- Diagnosis of B-cell precursor acute lymphoblastic leukemia (BCP-ALL) based on morphology, immunophenotyping, and clinical assessment.
- Prior clinical testing suggesting MEF2D rearrangement, with confirmation of the MEF2D rearrangement and its specific fusion partner during screening by RNA sequencing or a targeted RNA fusion panel.
- Meets either of the following baseline disease-status criteria:
Key exclusion criteria (20 listed)
- Isolated extramedullary relapse, or active extramedullary leukemia without bone marrow disease meeting one of the protocol-defined enrollment pathways.
- Active central nervous system leukemia.
- Failure to confirm MEF2D rearrangement during screening.
- White blood cell count ≥25 × 10^9/L before the first dose despite cytoreduction, or an unacceptable risk of leukostasis, tumor lysis syndrome, severe infection, severe bleeding, or other acute complications as judged by the investigator.
- Inadequate washout from prior therapy:
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 |
|---|---|---|
| Ifupinostat HydrochlorideAlso: BEBT-908Ifupinostat hydrochloride (BEBT-908) will be administered intravenously at a dose of 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to 2 cycles. Each dose will be administered as a constant-rate intravenous infusion over 30 ± 5 minutes. | Drug | BEBT-908 Monotherapy |
Primary outcome
Overall Response Rate in Participants With Relapsed/Refractory Disease
Time frame: From first dose through Cycle 2 Day 21 ± 3 days (approximately 6 weeks)
The proportion of participants with relapsed/refractory MEF2D-rearranged BCP-ALL who achieve a best overall response of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) during the first 2 treatment cycles.
Complete MRD Response Rate in Participants With MRD-Positive Disease
Time frame: From first dose through Cycle 2 Day 21 ± 3 days
The proportion of participants with morphologic remission but MRD-positive MEF2D-rearranged BCP-ALL who achieve a complete MRD response, defined as flow cytometry MRD <0.01% and MEF2D fusion transcript/ABL1 <0.1% at the same assessment time point, with both measurements evaluable.
3 secondary outcomes
Overall Survival
Time frame: From first dose until death or last known follow-up, up to approximately 30 months
Event-Free Survival
Time frame: From first dose until an EFS event or last follow-up, up to approximately 30 months
Incidence of Adverse Events and Serious Adverse Events
Time frame: From first dose through 28 days after the last dose
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 2 Oct 2026.
- 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.
The first affiliated hospital of soochow university
Suzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ifupinostat Hydrochloride in people with B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 19 inclusion and 20 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 2 Oct 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate in Participants With Relapsed/Refractory Disease (time frame: From first dose through Cycle 2 Day 21 ± 3 days (approximately 6 weeks)). The study lists 2 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 2 Oct 2026.