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

Prior treatment

• Patients who have received anticancer therapy prior to administration.
• 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.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.

Other illness

• Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
• 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.
• 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.
• A history of alcohol/drugs abuse.

Lab values

• 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.

Other

• Acute promyelocytic leukemia (APL).
• Patients with isolated extramedullary leukemia and multiple myeloma.
• Patients with uncontrolled active central nervous system leukemia (CNSL).
• Poor compliance.
• Current pregnancy or breastfeeding.

• 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.