BL-M11D1 for Acute Myeloid Leukemia

Recruiting at 13 trial locations

Overseen By Whitney Eakins

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SystImmune Inc.

Must not be taking: Immunosuppressants, Antihypertensives, Anticancer, others

Disqualifiers: Heart disease, Autoimmune diseases, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BL-M11D1 for individuals with acute myeloid leukemia (AML) that has returned or is unresponsive to standard treatments. The primary goal is to determine the safety and effectiveness of BL-M11D1 in combating this type of blood cancer. Participants will receive the treatment on different schedules to identify the most effective approach. This trial may suit those with CD33-positive AML, indicating a specific marker on the cancer cells, who have not succeeded with other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain anticancer therapies and other treatments like chemotherapy, biological therapy, and immunotherapy at least 2 weeks before starting the study. If you're on mitomycin or nitrosoureas, you need to stop them 6 weeks before. It's best to discuss your specific medications with the trial team to see if they need to be paused.

Is there any evidence suggesting that BL-M11D1 is likely to be safe for humans?

Research has shown that BL-M11D1, a new treatment being tested for acute myeloid leukemia, has been safe for patients so far. Studies indicate that most patients tolerate it well, and there are promising signs of its ability to fight cancer. However, the study is ongoing to better understand the treatment's safety and determine the best dose for future use. Researchers continue to collect information to fully assess any side effects and how patients respond to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute myeloid leukemia?

Most treatments for acute myeloid leukemia (AML), like chemotherapy, work by killing rapidly dividing cells, but they often lack precision and can damage healthy cells. BL-M11D1 stands out because it targets specific pathways involved in leukemia cell survival, potentially offering a more precise attack on cancer cells while sparing normal cells. Researchers are excited about BL-M11D1 as it could provide a more targeted approach, reducing side effects and improving outcomes for patients with AML. Additionally, the treatment's flexible dosing schedule, with options for administration on different days, could offer more convenience and adaptability to patient needs.

What evidence suggests that BL-M11D1 might be an effective treatment for acute myeloid leukemia?

Research has shown that BL-M11D1 may help treat acute myeloid leukemia (AML). This treatment uses a CD33 antibody-drug conjugate (ADC), a type of targeted therapy designed to attack cancer cells directly. Early studies have found that BL-M11D1 is generally safe and shows promising results in patients whose AML has returned or is resistant to other treatments. Participants in this trial will be assigned to different cohorts to receive BL-M11D1. Specifically, one study found that patients who received doses between 0.6 mg/kg and 2.75 mg/kg responded positively. These initial findings suggest that BL-M11D1 could be a promising option for people with hard-to-treat AML. ^{1 2 3 6 7}

Who Is on the Research Team?

Tara Barrineau

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

This trial is for people with Acute Myeloid Leukemia (AML) who have tried other treatments that didn't work. Participants should be in a condition where they can handle the study procedures and follow-up visits.

Inclusion Criteria

My AML has returned or didn't respond to first treatment and tests positive for CD33.

Has a life expectancy of ≥3 months

Signed the informed consent

Exclusion Criteria

I have recently used cancer treatments.

Recent use of investigational drugs

I have been diagnosed with APL or CML in blast crisis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BL-M11D1 in a dose-escalation format to determine the maximum tolerated dose

28 days per cycle

1 visit (in-person) per cycle

Dose Finding

Participants receive BL-M11D1 to determine the minimum safe and effective dose

28 days per cycle

1 visit (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• BL-M11D1

Trial Overview The trial is testing BL-M11D1, a new potential treatment for AML. It's an open-label study, meaning both doctors and patients know what's being given. They're looking at how safe it is, how the body processes it, and if it helps against AML.

How Is the Trial Designed?

Group I: Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycle Experimental Treatment 1 Intervention

Cohort B: BL-M11D1 will be administered on Days 1,4, 7 or 8 by intravenous infusion every 28 days.

Group II: Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycle Experimental Treatment 1 Intervention

Cohort A: BL-M11D1 will be administered on Days 1, 8 and 15 by intravenous infusion every 28 days.

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials

23

Recruited

1,800+

Published Research Related to This Trial

In a phase 1 study involving 23 patients with relapsed/refractory acute myeloid leukemia (AML), the combination of selinexor with mitoxantrone, etoposide, and cytarabine showed an overall response rate of 43%, with 26% of patients achieving complete remission.

The maximum tolerated dose of selinexor was determined to be 30 mg/m2 due to dose-limiting side effects, including hyponatremia, indicating that while the treatment is promising, careful monitoring for toxicity is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of selinexor in combination with salvage chemotherapy in Adults with relapsed or refractory Acute myeloid leukemia. Bhatnagar, B., Zhao, Q., Mims, AS., et al.[2023]

Selinexor, a selective inhibitor of nuclear export, was found to be safe and well-tolerated in a phase 1 study involving 95 patients with relapsed or refractory acute myeloid leukemia (AML), with manageable side effects primarily being mild gastrointestinal and constitutional toxicities.

The study showed that 14% of evaluable patients achieved an objective response, leading to significantly improved progression-free survival (5.1 months vs. 1.3 months) and overall survival (9.7 months vs. 2.7 months) compared to nonresponders, indicating its potential efficacy as a treatment for AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia. Garzon, R., Savona, M., Baz, R., et al.[2021]

Selinexor is a novel oral medication being investigated for treating acute myeloid leukemia (AML), which is particularly challenging to treat in older adults.

This meta-analysis aims to assess the efficacy and safety of selinexor in AML treatment by reviewing randomized controlled trials, providing valuable evidence to guide clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of selinexor in the treatment of AML: A protocol for systematic review and meta-analysis. Yu, L., Yin, X., Si, Y., et al.[2023]

In a study of 46 newly diagnosed acute myeloid leukemia (AML) patients, GLI-1 was found to be overexpressed in bone marrow samples, particularly in patients with poor risk categories, indicating its potential role as a prognostic marker.

Higher levels of GLI-1 mRNA were associated with a lack of complete remission after chemotherapy, suggesting that GLI-1 overexpression could be a novel therapeutic target for improving outcomes in AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High GLI-1 Expression is a Reliable Indicator of Bad Prognosis in Newly Diagnosed Acute Leukemia Patients. El Zaiat, RS., Nabil, R., Khalifa, KA., et al.[2023]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4260/533528/BL-M11D1-a-Novel-CD33-Antibody-Drug-Conjugate-ADC

BL-M11D1, a Novel CD33 Antibody-Drug Conjugate (ADC), in ... As of July 25, 2024, 39 patients were enrolled at doses ranging from 0.6 mg/kg to 2.75 mg/kg, with a median age of 53.9 years (range: 19-75 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06714591

Study Details | NCT06714591 | Evaluate the Safety, ... BL-M11D1-HM-101 is a multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124070186

BL-M11D1, a Novel CD33 Antibody-Drug Conjugate (ADC) ... The preliminary results of this phase I study have demonstrated BL-M11D1 monotherapy with an acceptable safety profile and encouraging anti-cancer activity.

4. systimmune.com systimmune.com/documents/2024-ASH-BL-M11D1.pdf

bl-m11d1, a novel cd33 antibody-drug conjugate (adc), in ... The safety and tolerability of BL-M11D1 in patients with R/R AML. • DLT and MTD. • Recommended Phase II Dose. Secondary outcome: • TEAE. • PK and PD data.

5. targetedonc.com targetedonc.com/view/fda-clears-ind-of-novel-adc-in-aml-treatment

FDA Clears IND of Novel ADC in AML Treatment The IND application of BL-M11D1, a CD33-binding ADC, has been cleared by the FDA, and a phase 1 study will commence to evaluate the agent in AML.

6. careacross.com careacross.com/clinical-trials/trial/NCT05924750

A Study of BLM11D1 in Patients With RelapsedRefractory ... Summary: Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated ...

7. trialx.com trialx.com/clinical-trials/listings/253083/a-study-of-bl-m11d1-in-patients-with-relapsedrefractory-acute-myeloid-leukemia/

A Study of BL-M11D1 in Patients With Relapsed/Refractory ... Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) ...