Acute Myeloid LeukemiaPhase 1NCT05703542
BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 1 study testing BXCL701 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2, run by Eric Stephen Winer, MD at 1 site in United States.
Trial summary
The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The names of the study drugs involved in this study are/is: BXCL701 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
- What is being tested?
- BXCL701
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 31 Dec 2026
- 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
- Age 18 and older
- Subjects with evidence of AML that meet at least one of the following criteria:
- Relapsed AML: as evidence by ≥5% myeloblasts in the bone marrow, or reappearance of blasts in the peripheral blood
- Refractory AML: ≤2 prior induction regimens (example: patients who receive 7 + 3 followed by 5 + 2 would count as one induction regimen) OR
- Subjects with WHO defined myelodysplastic syndrome with excess blasts-2 (MDS-EB-2) as defined by blast count between 10% - 19% in the bone marrow or peripheral blood blasts 5% - 19% or Auer rods noted and who are refractory or relapsed after at least 4 cycles of a hypomethylating agent (azacitidine, decitabine, or oral decitabine/cedazuridine)
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix B).
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- Participants must have adequate organ and marrow function as defined below:
- Estimated Creatinine Clearance ≥30 mL/min by Cockcroft-Gault calculation
- Total Bilirubin ≤1.5 x ULN*
- ALT and AST ≤3x ULN*
- EF >35%: *unless considered due to leukemic organ involvement. NOTE: Subjects with Gilbert's Syndrome may have a total bilirubin >1.5 x ULN per discussion with overall study PI.
- WBC <25,000 / µL on day of 1 of cycle 1; cytoreduction is permitted with hydroxyurea which is allowed throughout cycle 1 until cycle 2 day 1
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with treated central nervous system (CNS) disease are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
- Male subjects must agree to refrain from unprotected sex and sperm donation from initial drug administration until 90 days after the last dose of study drug.
- Females of childbearing potential (i.e not postmenopausal for at least 1 year or not surgically sterile) must have negative results by a serum pregnancy test performed within 7 days of day 1. Females must agree to refrain from unprotected sex/adequate contraception via barrier method from initial drug administration until 90 days after the last dose of study drug.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects who have known Acute Promyelocytic Leukemia.
- Subjects with active CNS involvement with AML.
- Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks or 5 half-lives from prior therapy, whichever is longer, prior to the first dose of study medication. Hydroxyurea is allowed with no required washout, and hydroxyurea may be administered for the first cycle of the protocol for patients who have proliferative disease (WBC <25K) with a maximum allowed dose of 6 g per day.
- Participants who have received oral tyrosine kinase inhibitors (TKIs) within two weeks or 5 half-lives (whichever is longer) of the first dose of study medication
- Subjects who are <100 days from allogeneic bone marrow transplant.
- Subjects who have active graft-versus host disease are not eligible. Patients should be off calcineurin inhibitors for at least 28 days (4 weeks) prior to start of study treatment C1D1
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- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities >Grade 1) with the exception of alopecia.
- Participants who are receiving any other investigational agents.
- Concomitant medications: It is strongly encouraged that patients who are on strong inducers or inhibitors of CYP3A4 be changed to a comparable drug if possible. If not possible, then dose reductions will need to be made as per APPENDIX C. Patients are not permitted to be on a gliptin (sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin).
- Patients with a history of orthostatic hypotension with a baseline SBP <100, or history of uncontrolled hypertension.
- Subject has cardiovascular disability status of NYHA class ≥2
- No concurrent active malignancies are allowed on study for ≥2 years prior to treatment start with the exception of currently treated basal cell or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix or breast, or low-grade prostate cancer.
- Patients with known active hepatitis B virus (HBV) infection should be excluded because of potential effects on immune function and/or drug interactions. However, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he/she would be eligible for study.
- Patients with known active hepatitis C virus (HCV) infection. Patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible.
- Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the patient or impair the assessment of study results. As patients with AML and MDS are prone to infections, if patients are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection control, then they will be considered eligible for study.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because BXCL701 has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.
- Inclusion of Women and Minorities: Both men and women of all races and ethnic groups are eligible for this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase 1 Study of BXCL701 in Relapsed/Refractory Acute Myeloid Leukemia or Relapsed/Refractory Myelodysplastic Syndrome With Excess Blasts - 2
The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
The names of the study drugs involved in this study are/is:
- BXCL701
Read the detailed description
This is a multi-center, single-arm, Phase I research study for the study drug, BXCL701, for participants with refractory or relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2). Phase I clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied. BXCL701 is a synthetic dipeptide that is in tablet form and is taken by mouth.
The U.S. Food and Drug Administration (FDA) has not approved BXCL701 as a treatment for any disease.
Research study procedures include screening for eligibility and study treatment including evaluations, blood collections, bone marrow biopsies, and follow up visits.
Participation in this study will last approximately 3 years.
It is expected that about 24 people will participate in this study.
BioXcel is supporting this research study by providing the study drug and funding research tests and procedures.
- Being tested
- BXCL701
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome with Excess Blasts-2, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL701Drug
Also called Talabostat
Tablet, taken Orally
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation BXCL701 | Experimental | Dose escalation will occur using a 3+3 dose escalation approach, evaluating 4 different dose levels of BXCL701.
During each 28 day study cycle participants will take BXCL701 2x daily for up to 12 cycles. Receives: Drug: BXCL701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Defined as the highest dose at which fewer than one-third of patients experience a dose-level toxicity (DLT). MTD will be used to inform recommended Phase II dose. If no DLTs are observed, the MTD is not reached.
Measured: From initiation of therapy to day 28, up to 35 days
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 4 weeks up to 1 year
Secondary outcomes (8)
Complete Remission (CR) Rate
Proportion of patients who have the response, criteria are based upon International Working Group (IWG) and European LeukemiaNet (ELN) criteria for Acute Myeloid Leukemia (APPENDIX D) and Myelodysplastic Syndrome (APPENDIX F).
Measured: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Complete Response with Incomplete Count Recovery (CRi) Rate
Proportion of patient who has the response, criteria are based upon International Working Group (IWG) and European LeukemiaNet (ELN) criteria for Acute Myeloid Leukemia (APPENDIX D) and Myelodysplastic Syndrome (APPENDIX F).
Measured: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Partial Response (PR) Rate
Based upon International Working Group (IWG) and European LeukemiaNet (ELN) criteria for AML (APPENDIX D) and MDS (APPENDIX F). Defined as decrease by >= 50% in blast percentage to 5-25% or to <= 5% with auer rods present in marrow; normalization neutrophil count >= 1000μL and platelet count >= 100000μL.
Measured: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days)..
Morphologic Leukemia-free State (MLFS) Rate
Evaluated only in AML patients per the 2017 ELN criteria (Dohner, Blood 2017, PMID: 27895058), defined as: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
Measured: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Hematologic Improvement (HI) Rate
Evaluated only in MDS-EB-2 patients.
Measured: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Median Overall Survival
OS is based on the Kaplan-Meier method, defined as the time from study entry to death or censored at date last known alive.
Measured: up to 2 years
Median Duration of Response (DOR)
Defined as the time of first morphologic response until the earlier of progression of disease or death due to any cause.
Measured: up to 2 years
Maximum Concentration (Cmax)
Defined as the maximum concentration of BCXL701 over the collection period.
Measured: Pharmacokinetic sampling is collected Cycle 1 Day 1, 3, 8, 15, Day 22, and Cycle 2 Day 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start2 Feb 2023
- Primary completion10 Oct 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Stephen Winer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Stephen Winer, MD, Dana-Farber Cancer Institute
- Investigators
- Eric S Winter, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703542
- Sponsor's protocol ID
- 22-379
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of BXCL701 in Relapsed/Refractory Acute Myeloid Leukemia or Relapsed/Refractory Myelodysplastic Syndrome With Excess Blasts - 2
- ClinicalTrials.gov ID
- NCT05703542
- Acronym / sponsor ID
- 22-379
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome with Excess Blasts-2, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eric Stephen Winer, MDUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2023 (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 goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
The names of the study drugs involved in this study are/is:
- BXCL701
Detailed description
This is a multi-center, single-arm, Phase I research study for the study drug, BXCL701, for participants with refractory or relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2). Phase I clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied. BXCL701 is a synthetic dipeptide that is in tablet form and is taken by mouth.
The U.S. Food and Drug Administration (FDA) has not approved BXCL701 as a treatment for any disease.
Research study procedures include screening for eligibility and study treatment including evaluations, blood collections, bone marrow biopsies, and follow up visits.
Participation in this study will last approximately 3 years.
It is expected that about 24 people will participate in this study.
BioXcel is supporting this research study by providing the study drug and funding research tests and procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation BXCL701 | Experimental | Drug: BXCL701Dose escalation will occur using a 3+3 dose escalation approach, evaluating 4 different dose levels of BXCL701. During each 28 day study cycle participants will take BXCL701 2x daily for up to 12 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 and older
- Subjects with evidence of AML that meet at least one of the following criteria:
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix B).
- Participants must have adequate organ and marrow function as defined below:
- WBC <25,000 / µL on day of 1 of cycle 1; cytoreduction is permitted with hydroxyurea which is allowed throughout cycle 1 until cycle 2 day 1
Key exclusion criteria (18 listed)
- Subjects who have known Acute Promyelocytic Leukemia.
- Subjects with active CNS involvement with AML.
- Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks or 5 half-lives from prior therapy, whichever is longer, prior to the first dose of study medication. Hydroxyurea is allowed with no required washout, and hydroxyurea may be administered for the first cycle of the protocol for patients who have proliferative disease (WBC <25K) with a maximum allowed dose of 6 g per day.
- Participants who have received oral tyrosine kinase inhibitors (TKIs) within two weeks or 5 half-lives (whichever is longer) of the first dose of study medication
- Subjects who are <100 days from allogeneic bone marrow transplant.
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 |
|---|---|---|
| BXCL701Also: TalabostatTablet, taken Orally | Drug | Dose Escalation BXCL701 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: From initiation of therapy to day 28, up to 35 days
Defined as the highest dose at which fewer than one-third of patients experience a dose-level toxicity (DLT). MTD will be used to inform recommended Phase II dose. If no DLTs are observed, the MTD is not reached.
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Time frame: 4 weeks up to 1 year
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
8 secondary outcomes
Complete Remission (CR) Rate
Time frame: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Complete Response with Incomplete Count Recovery (CRi) Rate
Time frame: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Partial Response (PR) Rate
Time frame: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days)..
Morphologic Leukemia-free State (MLFS) Rate
Time frame: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Hematologic Improvement (HI) Rate
Time frame: Disease assesment at baseline, cycle 1, 3 , 8, 15 , 22, and day 1 of every cycle and up to 12 cycles, corresponding to a treatment duration up to one year (each cycle is 28 days).
Median Overall Survival
Time frame: up to 2 years
Median Duration of Response (DOR)
Time frame: up to 2 years
Maximum Concentration (Cmax)
Time frame: Pharmacokinetic sampling is collected Cycle 1 Day 1, 3, 8, 15, Day 22, and Cycle 2 Day 1 (each cycle is 28 days)
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Eric S Winter, MD principal investigator
Dana-Farber Cancer Institute
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 BXCL701 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2, run by Eric Stephen Winer, MD 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 19 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 19 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 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 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?
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?
Maximum Tolerated Dose (MTD) (time frame: From initiation of therapy to day 28, up to 35 days). 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 19 Oct 2026.