Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

NCT06118788 | Recruiting Phase 1 DMC

• 1 other identifier: BG-CA-22-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

This is a single-arm, single-dose dose-escalation and dose-expansion study.

Conditions

Leukemia, Myeloid, Acute

Keywords

CAR-T; AML; CLL1

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity Rate

  After the infusion of BG1805, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to BG1805 infusion after optimal supportive treatment.

  Up to 28 days after BG1805 infusion.

• Incidence of Treatment-Emergent Adverse Events

  Count the Incidence of adverse events.

  Up to 24 months.

Secondary Outcomes (3)

• Concentration of CAR-T cells after Infusion (PK)

  Up to 24 months.

• overall response rate, ORR

  Up to 24 months.

• Concentration of Cytokine after Infusion (PD)

  Up to 24 months.

Study Arms (1)

BG1805

EXPERIMENTAL

Dose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of BG1805 injection and to determine the MTD and/or the recommended phase II dose (RP2D). Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of BG1805 injection, and to preliminarily evaluate its effectiveness.

Biological: BG1805

Interventions

BG1805 BIOLOGICAL

A single infusion of BG1805 Injection administered intravenously.

BG1805

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent and be expected to complete the follow-up examination and treatment of the study procedures.
• Age of 18-70 years old (inclusive of the cut-off value), regardless of gender.
• Conforming to the diagnosis of AML according to the 2016 WHO classification, and conforming to the diagnostic criteria of relapsed and refractory acute myeloid leukemia in Chinese Guidelines for the Diagnosis and Treatment of relapsed and refractory acute myeloid Leukemia (2017 edition) :
• Relapsed AML diagnostic criteria: the reappearance of peripheral blood or bone marrow blasts after complete remission (CR); 5% (excluding other causes such as bone marrow regrowth after consolidation chemotherapy) or extramedullary leukemic cell infiltration.
• Refractory AML diagnostic criteria: newly diagnosed patients who failed to response to 2 courses of standard regimens; Patients who relapsed within 12 months after consolidation and intensive therapy; Patients relapsed after 12 months but failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
• Flow cytometry confirmed the AML Blast CLL-1 expression positive (CLL-1 expression ≥50%).
• The patient has recovered from the toxicity of previous treatment, defined as CTCAE toxicity grade \<2 (unless the abnormality is tumor-related or is judged by the investigator to be stable and has little effect on safety or efficacy).
• ECOG performance status of 0-1 and predicted survival of more than 3 months.
• Have appropriate organ functions:
• Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN)
• Alanine aminotransferase (ALT) ≤3 times ULN
• Total bilirubin ≤1.5 times ULN
• Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/ minute
• Hemoglobin ≥60g/L or maintained at that level after transfusion
• Refers to terminal oxygen saturation ≥92%

You may not qualify if:

• Acute promyelocytic leukemia was diagnosed.
• Have other malignant tumors within 3 years before screening, excluding adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy.
• Evidence of central nervous system involvement or cranial neuropathy.
• Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
• Those with a history of anaphylaxis \[A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest\] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
• Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.
• Previous organ transplantation or preparation for organ transplantation (excluding hematopoietic stem cell transplantation).
• Acute and chronic graft-versus-host disease (GVHD).
• Patients who had undergone hematopoietic stem-cell transplantation within 6 months before screening.
• Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
• Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.
• Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.
• Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.
• Persons with severe mental illness.
• Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Study Sites (3)

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• He Huang, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Luo, Doctorate

CONTACT

+86 020 32030437; mluo@gzbiogene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (3)