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Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

ConditionRelapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSystImmune Inc.

About this trial

The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed the informed consent

Age ≥18 years

Has a life expectancy of ≥3 months

Relapsed and/or refractory CD33-positive AML as determined by local pathology review that has failed initial standard of care therapy. Diagnosis of primary AML or AML secondary to myelodysplastic syndromes. Relapsed or refractory status. CD33-positive as confirmed by local flow cytometry or cytology

Disqualifiers

Subjects with acute promyelocytic leukemia (APL) or chronic myelogenous leukemia in blast crisis (CML)

Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy within 2 weeks) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration, or palliative radiotherapy within 2 weeks prior to the first administration

Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable cardiac arrhythmias or angina pectoris within 6 months before screening

Subjects with prolonged QT interval (QTcF >470 msec), complete left bundle branch block, Grade 3 atrioventricular block or a history of additional risk factors for Torsades de Pointes (TdP; eg, heart failure as defined in Exclusion Criterion 3, chronic or recurrent hypokalemia that requires medical intervention, congenital long QT syndrome, family history of long QT syndrome) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP

Trial design

Design model

Sequential

Treatments tested in this trial

  • BL-M11D1

    Drug

    The study includes 2 parts: Part 1 Dose escalation and Dose Finding

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycleExperimental treatment 1 intervention
Group B: Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participants with dose-limiting toxicities

DLTs are defined as any of the following events that are not clearly due to the underlying disease, disease progression, or extraneous causes: * Any treatment-emergent adverse event (TEAE) of ≥ Grade 3 except those due to disease progression or extraneous cause * Any TEAE that leads to dose reduction or withdrawal Nonhematologic toxicities * Death * Hy's law cases * Grade ≥3 nonhematologic toxicities (with exceptions) Hematologic toxicity * Grade 4 thrombocytopenia or neutropenia lasting \>42 days in the absence of persistent leukemia * Grade ≥3 platelet count decreased with clinically significant hemorrhage

Time frame
1 Year
2

Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)

Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

Time frame
1 Year
3

To determine the minimum safe and effective dose (MSED), maximum tolerated dose (MTD) if reached, and maximum administered dose (MAD) of BL-M11D1 in AML

Determine the highest BL-M11D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-M11D1 dose administered in the event and MTD cannot be defined.

Time frame
1 Year

Secondary outcomes

1

Cmax of BL-M11D1

Calculate maximum (peak) observed concentration of BL-M11D1

Time frame
1 Year
2

Tmax of BL-M11D1

Calculate time of maximum observed concentration of BL-M1D1

Time frame
1 Year
3

Tmax of free payload ED-04

Calculate time of maximum observed concentration of free payload ED-04

Time frame
1 Year
4

Cmax of free payload ED-04

Calculate maximum (peak) observed concentration of free payload ED-04

Time frame
1 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SystImmune Inc.

Lead sponsor

Source ClinicalTrials.gov
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