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OncoMatch/Clinical Trials/NCT06714591

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

Is NCT06714591 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies BL-M11D1 for relapsed/refractory acute myeloid leukemia.

Phase 1RecruitingSystImmune Inc.NCT06714591Data as of Sep 2026

Treatment: BL-M11D1The 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.

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Extracted eligibility criteria

Treatments studied

Other

BL-M11D1

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: CD33 expression (testing required; no eligibility threshold specified)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: standard of care therapy

Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate

Lab requirements

Kidney function

creatinine clearance ≥50 ml/min (cockcroft-gault, ckd-epi, or mdrd equations)

Liver function

total bilirubin (tbil) ≤1.5×uln (≤3×uln for subjects with gilbert's syndrome), ast and alt ≤2.5×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • UCLA Ronald Reagan Medical Center · Los Angeles, California
  • University of Colorado Anschutz Medical Campus · Aurora, Colorado
  • Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven · New Haven, Connecticut
  • Moffitt Cancer Center · Tampa, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06714591 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior topoisomerase inhibitor-based antibody-drug conjugate disqualifies patients from enrollment.

Does this trial require CD33?

Yes, CD33 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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