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

ConditionsRelapsed or Refractory Hematologic MalignanciesLeukemiaLymphomaMultiple Myeloma (MM)
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • BT02

    Drug

    BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Treatment groups

116 Participants
are divided into 1 treatment group
Group A: dose escalation and expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Time frame
Through the study completion, an average of 2.5 years
2

Dose limited toxicity(DLT)

Time frame
Through the dose escalation phase, an average of 10 months
3

Maximum tolerable dose(MTD)

Time frame
Through the dose escalation phase, an average of 10 months
4

Recommended phase 2 dose(RP2D)

Time frame
Through the study completion, an average of 2.5 years

Secondary outcomes

1

Objective response rate (ORR) on tumor assessments

Time frame
Through the study completion, an average of 2.5 years
2

Progression-free survival (PFS) on tumor assessments

Time frame
Through the study completion, an average of 2.5 years
3

Overall survival (OS)

Time frame
Through the study completion, an average of 2.5 years
4

Duration of response (DoR) on tumor assessments

Time frame
Through the study completion, an average of 2.5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biotroy Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: