NCT07107204Not yet recruitingPhase 1
A Multicenter, Open-label, Single-arm Phase Ib/IIa Clinical Study to Evaluate the Safety and Efficacy of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies
Not provided0 sites116 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 116
- Primary Endpoint
- Adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •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.
Exclusion Criteria
- •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.
- •Current pregnancy or breastfeeding.
- •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.
Arms & Interventions
dose escalation and expansion
Experimental
Intervention: BT02 (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: Through the study completion, an average of 2.5 years
Dose limited toxicity(DLT)
Time Frame: Through the dose escalation phase, an average of 10 months
Maximum tolerable dose(MTD)
Time Frame: Through the dose escalation phase, an average of 10 months
Recommended phase 2 dose(RP2D)
Time Frame: Through the study completion, an average of 2.5 years
Secondary Outcomes
- 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)
- Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level(Through the study completion, an average of 2.5 years)
- Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level(Through the study completion, an average of 2.5 years)
- ADA and NAb incidence(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)
Investigators
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