A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBiotroy Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- BT02
Treatment groups
116 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov