A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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%

⁃ Left ventricular ejection fraction (LVEF) ≥45%

• Female subjects were also considered for inclusion if they met the following criteria:

∙ Infertility, defined as:

⁃ Prior hysterectomy or bilateral oophorectomy, or

• Prior bilateral tubal ligation, or

• Menopausal (≥ 1 year of complete amenorrhea)

‣ be fertile, but have a negative serum pregnancy test at screening, and agree to use a medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) before and during study enrollment and up to 1 year after the last study use.

• Men of childbearing potential had to agree to barrier contraception or complete abstinence until 1 year after the last study dose.

Locations
Other Locations
China
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Min Luo, Doctorate
mluo@gzbiogene.com
+86 020 32030437
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2027-07
Participants
Target number of participants: 24
Treatments
Experimental: BG1805
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.
Related Therapeutic Areas
Sponsors
Leads: Guangzhou Bio-gene Technology Co., Ltd

This content was sourced from clinicaltrials.gov