A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

NCT05148442 | Terminated Phase 1

• 1 other identifier: CIBI322A106
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Conditions

Myeloid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of treatment related AEs

  safety and tolerability

  Up to 90 days post last dose

Secondary Outcomes (1)

• Number of patients with response

  Last patient enrolled+24 weeks

Study Arms (1)

IBI322

EXPERIMENTAL

Drug: IBI322

Interventions

IBI322 DRUG

Recombinant anti-human CD47/PD-L1 bispecific antibody

IBI322

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
• Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
• Male or female subject above 18 years old
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 \~ 2.
• Must have adequate organ function

You may not qualify if:

• Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
• Transformation or treatment related AML/MDS.
• PV/MF/AML/MDS evolved from Essential thrombocythemia
• Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
• Central nervous system leukemia infiltration
• Previous history of chronic hemolytic anemia or screening Coombe test positive
• Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
• Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
• Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
• Uncontrolled concurrent diseases
• Subjects who are allergic to the ingredients of the study drug
• Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: December 28, 2021
• Primary Completion: June 19, 2023
• Study Completion: August 29, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)