A Phase I Study of BR108 in Hematological Malignancies

NCT06018506 | Terminated Phase 1

• 1 other identifier: BR108
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I study of BR108 in hematological malignancies

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose Limiting Toxicity (DLT)

  Dose limiting toxicity

  up to 28 days

• 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.

  up to approximately 3 years

Secondary Outcomes (4)

• Cmax

  up to approximately 3 years

• Tmax

  up to approximately 3 years

• Incidence of antidrug antibodies (ADA)

  up to approximately 3 years

• Duration of remission (DOR)

  up to approximately 3 years

Study Arms (1)

BR108

EXPERIMENTAL

Drug: BR108 injection

Interventions

BR108 injection DRUG

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

BR108

Eligibility Criteria

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

You may qualify if:

• \. Voluntary agreement to provide written informed consent;
• \. Males and females who are ≥18 years old;
• \. 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；
• \. Subjects must have documented CD70-positive .
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• \. Expected survival time ≥3 months;
• Have at least 1 evaluable lesion per Lugano 2014;
• \. 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:
• \. 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.
• \. Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study.

You may not qualify if:

• \. Pregnant or lactating women;
• \. 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);
• \. 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;
• \. Previous exposure to CD70-targeted agents;
• \. Patients with Allergic history or hypersensitivity reaction to any components of BR108 injection;
• \. 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);
• \. 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）;
• \. HBsAg or HBcAb positive, and HBV DNA positive; HCVAb positive and HCV RNA positive; HIV positive; syphilis infection requiring systematic treatment ;
• \. 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;
• \. 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);
• \. 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.

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

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: August 11, 2023
• First Posted: August 30, 2023
• Study Start: March 18, 2023
• Primary Completion: May 27, 2024
• Study Completion: June 21, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)