A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies

NCT ID: NCT07107204

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-04-30

Brief Summary

The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with relapsed or refractory hematologic malignancies, regardless of gender, aged between 18(inclusive) and 70 years .

Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.

Conditions

Relapsed or Refractory Hematologic Malignancies; Leukemia; Lymphoma; Multiple Myeloma (MM)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dose escalation and expansion

Group Type: EXPERIMENTAL

BT02

Intervention Type: DRUG

BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Interventions

BT02

BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.

2. Age:≥18 and <70 years, any gender.

3. Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .

4. Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.

5. Measurable Disease.

6. Relapsed/Refractory Status.

7. Adequate organ and hematologic function.

8. An ECOG activity status score of 0-1.

9. A life expectancy of ≥ 3 months.

10. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.

Exclusion Criteria

1. Acute promyelocytic leukemia (APL).

2. Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.

3. Patients with isolated extramedullary leukemia and multiple myeloma.

4. Patients with uncontrolled active central nervous system leukemia (CNSL).

5. Patients who have received anticancer therapy prior to administration.

6. A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.

7. A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities ,severe pulmonary disease that may lead to severe episodes of dyspnea,head trauma, impaired consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhagic disease.

8. A severe acute or chronic infection when enrollment.

9. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .

10. Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.

11. Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.

12. A history of other type of malignancies.

13. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.

14. Poor compliance.

15. A history of alcohol/drugs abuse.

16. Current pregnancy or breastfeeding.

17. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotroy Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Central Contacts

Clinical development director

Role: CONTACT

clin.oper@biotroy.cn

+86-18602185973

Other Identifiers

BT02-201

Identifier Type: -

Identifier Source: org_study_id