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

NCT07107204 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BT02-201
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Through the study completion, an average of 2.5 years

• Dose limited toxicity(DLT)

  Through the dose escalation phase, an average of 10 months

• Maximum tolerable dose(MTD)

  Through the dose escalation phase, an average of 10 months

• Recommended phase 2 dose(RP2D)

  Through the study completion, an average of 2.5 years

Secondary Outcomes (8)

• Objective response rate (ORR) on tumor assessments

  Through the study completion, an average of 2.5 years

• Progression-free survival (PFS) on tumor assessments

  Through the study completion, an average of 2.5 years

• Overall survival (OS)

  Through the study completion, an average of 2.5 years

• Duration of response (DoR) on tumor assessments

  Through the study completion, an average of 2.5 years

• Disease control rate (DCR) on tumor assessments

  Through the study completion, an average of 2.5years

Study Arms (1)

dose escalation and expansion

EXPERIMENTAL

Drug: BT02

Interventions

BT02 DRUG

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

dose escalation and expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.
• Age:≥18 and \<70 years, any gender.
• Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .
• Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.
• Measurable Disease.
• Relapsed/Refractory Status.
• Adequate organ and hematologic function.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.

You may not qualify if:

• Acute promyelocytic leukemia (APL).
• Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
• Patients with isolated extramedullary leukemia and multiple myeloma.
• Patients with uncontrolled active central nervous system leukemia (CNSL).
• Patients who have received anticancer therapy prior to administration.
• A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
• 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.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• 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.
• Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol/drugs abuse.

Sponsors & Collaborators

• Biotroy Therapeutics: lead

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms; Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Ying Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical development director

CONTACT

+86-18602185973; clin.oper@biotroy.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-07