New antibody BT02 takes on Hard-to-Treat blood cancers
NCT ID NCT07107204
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial tests a new drug called BT02, a monoclonal antibody, in 116 adults with relapsed or refractory blood cancers like leukemia, lymphoma, or multiple myeloma. Participants receive the drug by IV every 2-3 weeks for up to two years. The main goals are to check safety, find the best dose, and see if the drug can shrink tumors or slow the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BT02 (a monoclonal antibody given by IV every 2-3 weeks)
- What this could lead to
- If it works, this could point toward a new treatment option for people with blood cancers that have stopped responding to standard therapy.
- What could go wrong
- This is a very early, small trial (Phase 1/2) focused on safety and dosing, so it is far from proving effectiveness. The drug may cause side effects or fail to control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double-Drug attack on Hard-to-Treat lymphomas
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Cell therapy targets a marker on myeloma cells
- Can a calming drug make cord blood transplants safer?
- Oral drug combo targets myeloma that escaped the bone marrow