Myeloid Tumor
Conditions
Brief summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.
Detailed description
Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.
Interventions
DRUGIBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment. 2. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment. 3. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia) 4. Male or female subject above 18 years old 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 \ 2. 6. Must have adequate organ function
Exclusion criteria
1. Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN 2. Transformation or treatment related AML/MDS. 3. PV/MF/AML/MDS evolved from Essential thrombocythemia 4. Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year 5. Central nervous system leukemia infiltration 6. Previous history of chronic hemolytic anemia or screening Coombe test positive 7. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. 8. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) 9. Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose 10. Uncontrolled concurrent diseases 11. Subjects who are allergic to the ingredients of the study drug 12. Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment related AEs | Up to 90 days post last dose | safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with response | Last patient enrolled+24 weeks | preliminary efficacy |
Countries
China
Outcome results
None listed