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Hematologic MalignancyPhase 1NCT06018506

A Phase I Study of BR108 in Hematological Malignancies

A Phase 1 study testing BR108 injection in people with Hematologic Malignancy, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Phase I study of BR108 in hematological malignancies Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Malignancy
What is being tested?
BR108 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
18 Mar 2023to 21 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntary agreement to provide written informed consent;
  • 2. Males and females who are ≥18 years old;
  • 3. Patients must have an advanced hematologic malignancy including： Relapsed or refractory lymphoma as defined by World Health Organization(WHO) criteria； Relapsed or refractory AML /MDSas defined by World Health Organization (WHO) criteria；
  • 4. Subjects must have documented CD70-positive .
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • 7. Expected survival time ≥3 months;
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  • 8.Have at least 1 evaluable lesion per Lugano 2014;
  • 9. The function of major organs must meet the following criteria (Lymphoma：have not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 7 days before the first dose of study drug) ：
  • White blood cell count≤25×109/L（for AML/MDS）
  • Absolute neutrophil count (ANC) ≥1.5×109/L or ≥0.75×109 /L for patients with bone marrow infiltration, Platelet ≥75×109 /L or ≥50×109 /L for patients with bone marrow infiltration; Hemoglobin ≥8.0mmol/L or ≥ 7.0mmol/L for patients with bone marrow infiltration;
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
  • serum creatinine≤1.5×ULN or Creatinine clearance rate ≥60 mL/min ;
  • Total bilirubin ≤1.5×ULN or ≤3×ULN for patients with Gilbert's syndrome or liver metastasis； Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN or ≤5×ULN for patients with liver metastasis:
  • 10. Women of child bearing potential and non-sterilized male patients who are sexually active with a female partner of child bearing potential must agree to use an effective method of contraception from screening until 6 months after the last dose of study drug. Effective methods of contraception consist of prior sterilization, intrauterine device, intrauterine hormone-releasing system, oral or injectable contraceptives, and sexual abstinence.
  • 11. Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study.

Who cannot join

  • 1. Pregnant or lactating women;
  • 2. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia, primary central nervous system malignancies or invasion of the central nervous system (except for those who are asymptomatic or stable and do not require treatment ≥4 weeks before the first dose of study drug);
  • 3. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCICTCAE5.0 ), except for alopecia, pigmentation and other toxicity judged no safety risk by the investigator;
  • 4. Previous exposure to CD70-targeted agents;
  • 5. Patients with Allergic history or hypersensitivity reaction to any components of BR108 injection;
  • 6. Patients with active bacterial, viral, fungal, mycobacterium, parasite or other infection (except fungal infection of nail bed) within 7 days prior to enrollment and requiring intravenous infusion therapy (except neoplastic fever);
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  • 7. Patients with inherited or acquired hemorrhagic diseases or severe coagulation abnormalities of clinical significance（ Such as diffuse intravascular coagulation (DIC) autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, sickle cell anemia, etc）;
  • 8. HBsAg or HBcAb positive, and HBV DNA positive; HCVAb positive and HCV RNA positive; HIV positive; syphilis infection requiring systematic treatment ;
  • 9. Subjects who have received live or attenuated vaccine within 4 weeks before the first administration or planned to receive live vaccine during the study period;
  • 10. History of any other malignancies within 3 years (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, cervical carcinoma in situ, stage I ductal carcinoma in situ of the breast, and malignancies that have been cured (CR) within 2 years prior to initial administration and are currently considered stable by the investigator with minimal risk of recurrence);
  • 11. Patients with serious cardiovascular and cerebrovascular diseases or other serious organic diseases, including but not limited to:
  • History of stroke 、intracranial hemorrhage 、unstable angina pectoris、 congestive heart failure (NYHA III-IV)、myocardial infarction、severe arrhythmias (e.g., persistent ventricular tachycardia, ventricular fibrillation) or congenital long QT syndrome within 6 months before enrollment.
  • Left ventricular ejection fraction （LVEF） < 50% in echocardiography (ECHO) or muti-gate detection scan (MUGA) .
  • Corrected QT interval prolongation >470ms.
  • Patients with interstitial lung disease, severe lung dysfunction, severe pulmonary fibrosis, or pulmonary infection requiring systematic treatment.
  • 12. Subjects who have autoimmune disorders and need to rely on immunosuppressive therapy or receive systemic therapy with a dose of ≥20mg/day of prednisone or other equivalent hormones within 2 weeks before enrollment;
  • 13. Patients have received other clinical trials within 4 weeks before the first dose of study drug;
  • 14.Subjects who have major surgery or severe trauma within 4 weeks prior to initial dosing or plan to take major surgery during the trial period;
  • 15. Treatment with prior anti-cancer therapy (including chemotherapy, endocrine therapy, targeted therapy, etc.) must have been terminated at last 28 days or 5 half-lives (whichever is shorter) before study enrolment,2 weeks for endocrine therapy and Chinese medicine treatment with anti-tumor indications or local palliative radiotherapy for bone metastasis and pain relief within 2 weeks.
  • 16. Prior allogeneic hematopoietic stem cell or organ transplantation; recent Autologous hematopoietic stem cell transplantation（less than 3 months prior first dosing of study drug）;
  • 17. Patients with any mental or cognitive impairment that may restrict the understanding and implementation of the informed consent;
  • 18. Other serious, uncontrollable concomitant diseases that may affect protocol compliance or interfere with outcomes, or other serious or uncontrollable medical conditions that the investigator believes may put subjects at risk for participating in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: A Phase I ,Single-arm, Open-label Study to Evalute the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Clinical Activity of BR108 Injection in Subjects With Hematological Malignancies

A Phase I study of BR108 in hematological malignancies

Being tested
BR108 injection
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • BR108 injectionDrug

    Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle

Study groups in NCT06018506
Study groupRoleWhat they receive
BR108ExperimentalNot described
Receives: Drug: BR108 injection

What is being measured

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

  1. Number of Participants with Dose Limiting Toxicity (DLT)

    Dose limiting toxicity

    Measured: up to 28 days

  2. objective response rate（ORR）

    FOR lymphoma ，Objective Response Rate is defined as the percentage of patients with a complete response (CR) or partial response (PR). For AML, the proportion of participants who achieve a best response of CR, CRi, MLFS, or partial response (PR). For MDS, the proportion of participants who achieve a best response of CR, marrow CR, or PR.

    Measured: up to approximately 3 years

Secondary outcomes (4)

  1. Cmax

    Cmax is the maximum observed concentration.

    Measured: up to approximately 3 years

  2. Tmax

    Time to maximum concentration attained

    Measured: up to approximately 3 years

  3. Incidence of antidrug antibodies (ADA)

    Percentage of patients producing detectable ADA

    Measured: up to approximately 3 years

  4. Duration of remission (DOR)

    To preliminarily evaluate DoR in patients with hematological malignancies

    Measured: up to approximately 3 years

Timeline

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

  1. First posted30 Aug 2023
  2. Study start18 Mar 2023
  3. Primary completion27 May 2024
  4. Study completion21 Jun 2024

Why it stopped: Adjustment of Company R\&D strategy

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018506
Sponsor's protocol ID
BR108
Status last verified
Nov 2025
First submitted
11 Aug 2023
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR108 injection in people with Hematologic Malignancy, run by BioRay Pharmaceutical Co., Ltd. at 1 site 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 15 inclusion and 22 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: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Adjustment of Company R\&D strategy). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicity (DLT) (time frame: up to 28 days). 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 NCT06018506.

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 21 Nov 2025.

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