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Leukemia, Myeloid, AcutePhase 1/2NCT06118788

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

A Phase 1/2 study testing BG1805 in people with Leukemia, Myeloid, Acute, run by Guangzhou Bio-gene Technology Co., Ltd at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, single-dose dose-escalation and dose-expansion study. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
BG1805
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesChina
Study dates
7 Mar 2024to Jul 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%).
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  • 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.

Who cannot join

  • 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.
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  • 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 .
  • Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.
  • hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.
  • Immunosuppressive agents: those who were receiving immunosuppressive agents within 2 weeks before PBMC collection.
  • Vaccination with live (attenuated) virus vaccine within 4 weeks prior to screening.
  • Alcoholics or those with a history of substance abuse.
  • Participate in other clinical investigators within 3 months.
  • Subjects who have received other CAR-T therapy or cell therapy in the past.
  • Patients who, in the investigator's judgment and/or clinical criteria, have contraindications to any study procedure or other medical conditions that may put them at unacceptable risk.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Min Luo, Doctorate contact

+86 020 32030437

mluo@gzbiogene.com

China3 sites, 3 recruiting

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Rui Huang, MD

    Rui Huang, MD

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Yu Zhang, MD

    Yu Zhang, MD

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    He Huang, MD

    He Huang, MD

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the detailed description

Patients with relapsed/refractory acute myeloid leukemia (r/r AML) were enrolled in the trial, which was divided into two parts: dose-escalation phase and dose-expansion phase.

Being tested
BG1805
Keywords
CAR-T, AML, CLL1
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG1805Biological

    A single infusion of BG1805 Injection administered intravenously.

Study groups in NCT06118788
Study groupRoleWhat they receive
BG1805ExperimentalDose 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.
Receives: Biological: BG1805

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days after BG1805 infusion.

  2. Incidence of Treatment-Emergent Adverse Events

    Count the Incidence of adverse events.

    Measured: Up to 24 months.

Secondary outcomes (3)

  1. Concentration of CAR-T cells after Infusion (PK)

    CAR-T in peripheral blood after infusion

    Measured: Up to 24 months.

  2. overall response rate, ORR

    Defined as the proportion of subjects achieving complete response(CR), complete remission with incomplete blood cell recovery (CRi), morphologic leukemia-free state (MLFS), or partial response(PR).

    Measured: Up to 24 months.

  3. Concentration of Cytokine after Infusion (PD)

    Calculate the change of cytokine concentration in peripheral blood after After BG1805 infusion. Cytokines include IL-2、IL-6 and so on.

    Measured: Up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start7 Mar 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118788
Sponsor's protocol ID
BG-CA-22-001
Status last verified
Apr 2025
First submitted
30 Oct 2023
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BG1805 in people with Leukemia, Myeloid, Acute, run by Guangzhou Bio-gene Technology Co., Ltd at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Min Luo, Doctorate (+86 020 32030437, mluo@gzbiogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limited Toxicity Rate (time frame: Up to 28 days after BG1805 infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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