NCT05190471 A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
| NCT ID | NCT05190471 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bio-Path Holdings, Inc. |
| Condition | Acute Myeloid Leukemia, in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-08-16 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2022-08-16 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active for refractory/relapsed AML 2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2 3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy 4. Participants must have adequate hepatic and renal functions as defined by: 1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and 2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And; 3. Estimated creatinine clearance of at least 60 mL/min. These estimations are calculated using the Cockcroft-Gault equation. 5. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine 6. Male participants must agree to use an acceptable method of contraception for the duration of the study 7. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment 8. Participants must be willing and able to provide written informed consent Exclusion Criteria: 1. Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months 2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening 3. Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required. 4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA 5. Chronic myeloid leukemia in any phase 6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis 7. Participants may not be receiving any other investigational agents 8. Female participants who are pregnant or breast-feeding 9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results 10. Participants with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts \< 350 cells/mcL or with clinically active hepatitis B or C infection 11. History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor 12. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia 13. Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \>470 msec) 14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack 15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months) 16. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason
Contact & Investigator
Gail J Roboz, MD
PRINCIPAL INVESTIGATOR
Weill Cornell Medical College - New York-Presbyterian Hospital
Frequently Asked Questions
Who can join the NCT05190471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia, in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05190471 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05190471 currently recruiting?
Yes, NCT05190471 is actively recruiting participants. Contact the research team at mhickey@biopathholdings.com for enrollment information.
Where is the NCT05190471 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, New York, United States, Houston, United States.
Who is sponsoring the NCT05190471 clinical trial?
NCT05190471 is sponsored by Bio-Path Holdings, Inc.. The principal investigator is Gail J Roboz, MD at Weill Cornell Medical College - New York-Presbyterian Hospital. The trial plans to enroll 48 participants.
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