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

Launched by BIOTROY THERAPEUTICS · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BT02 for adults aged 18 to 70 who have certain blood cancers, such as leukemia, lymphoma, or multiple myeloma, that have come back after previous treatment or have not responded to treatment. The main goal is to find out if BT02 is safe, how well patients can tolerate it, and whether it might help control the disease.

If you join the study, you will receive the treatment through an IV (a drip into your vein) every two or three weeks, for up to two years, as long as the cancer does not get worse and side effects are manageable. To be eligible, participants must have a confirmed diagnosis of these blood cancers, measurable disease, and be generally healthy enough to take part (with good organ function and activity levels). People with certain other health problems, recent treatments, or specific cancer types are not eligible. It’s important to know that this trial is still not recruiting patients yet, but it aims to help find new options for those with challenging blood cancers.

Gender

ALL

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.