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NCT04485052 Clinical Trial

Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04485052
Other study ID # CIBI188B201
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date September 25, 2020
Est. completion date December 31, 2024

Study information
Verified date October 2023
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Recruitment information / eligibility
Status Suspended
Enrollment 222
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML). 2. Relapsed// refractory AML( =18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( =60 ys). 3. Age =18 years old, gender not limited. 4. ECOG score of 0-2. 5. Adequate organ function. Exclusion Criteria: 1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase). 2. A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients. 3. Major surgery and vaccine treatment within 4 weeks. 4. Uncontrolled concurrent diseases. 5. Pregnant or breastfeeding female subjects.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IBI188
anti-CD47 Monoclonal antibody
• Azacitidine
Demethylation drugs
• Decitabine
Demethylation drugs

Locations
Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite complete rate Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery 24 weeks
Secondary Cytogenetic CR 24 weeks
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