Relapsed or Refractory Hematologic MalignanciesPhase 1/2NCT07107204
A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1/2 study testing BT02 in people with Relapsed or Refractory Hematologic Malignancies and Leukemia, run by Biotroy Therapeutics.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory Hematologic Malignancies, Leukemia, Lymphoma
- What is being tested?
- BT02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Relapsed or Refractory Hematologic Malignancies, Leukemia, Lymphoma, Multiple Myeloma (MM)
- Being tested
- BT02
- Medical subject headings
- Recurrence, Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT02Drug
BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| dose escalation and expansion | Experimental | Not described Receives: Drug: BT02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Through the study completion, an average of 2.5 years
Dose limited toxicity(DLT)
Measured: Through the dose escalation phase, an average of 10 months
Maximum tolerable dose(MTD)
Measured: Through the dose escalation phase, an average of 10 months
Recommended phase 2 dose(RP2D)
Measured: Through the study completion, an average of 2.5 years
Secondary outcomes (8)
Objective response rate (ORR) on tumor assessments
Measured: Through the study completion, an average of 2.5 years
Progression-free survival (PFS) on tumor assessments
Measured: Through the study completion, an average of 2.5 years
Overall survival (OS)
Measured: Through the study completion, an average of 2.5 years
Duration of response (DoR) on tumor assessments
Measured: Through the study completion, an average of 2.5 years
Disease control rate (DCR) on tumor assessments
Measured: Through the study completion, an average of 2.5years
Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level
Measured: 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
Measured: Through the study completion, an average of 2.5 years
ADA and NAb incidence
Measured: Through the study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotroy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Wang, MD, Principal investigator, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107204
- Sponsor's protocol ID
- BT02-201
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07107204
- Acronym / sponsor ID
- BT02-201
- Conditions
- Relapsed or Refractory Hematologic Malignancies, Leukemia, Lymphoma, Multiple Myeloma (MM)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Biotroy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation and expansion | Experimental | Drug: BT02 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT02BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks | Drug | dose escalation and expansion |
Primary outcome
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
8 secondary outcomes
Objective response rate (ORR) on tumor assessments
Time frame: Through the study completion, an average of 2.5 years
Progression-free survival (PFS) on tumor assessments
Time frame: Through the study completion, an average of 2.5 years
Overall survival (OS)
Time frame: Through the study completion, an average of 2.5 years
Duration of response (DoR) on tumor assessments
Time frame: Through the study completion, an average of 2.5 years
Disease control rate (DCR) on tumor assessments
Time frame: Through the study completion, an average of 2.5years
Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level
Time frame: 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
Time frame: Through the study completion, an average of 2.5 years
ADA and NAb incidence
Time frame: Through the study completion, an average of 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Wang, MD principal investigator
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BT02 in people with Relapsed or Refractory Hematologic Malignancies and Leukemia, run by Biotroy Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical development director (+86-18602185973, clin.oper@biotroy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through the study completion, an average of 2.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.