Clinical trial · Interventional
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
NCT04795128CI-TRIAL-00082294completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI322 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- IBI322
- description
- Single arm
- interventionNames
- Biological: IBI322
Primary outcomes (2)
- measure
- Number of treatment related AEs
- timeFrame
- Up to 90 days post last dose
- description
- Safety
- measure
- Number of patients with response
- timeFrame
- Last patient enrolled +24 weeks
- description
- Preliminary Efficacy
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment 2. At least one evaluable lesion 3. Male or female 18 to 75 years old 4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2 5. Must have adequate organ function Exclusion Criteria: 1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein 2. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) 3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies 4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start 5. A history of blood transfusion within 2 weeks prior to study start
References
Publications (0)
Data not yet available
No reference posted for this study.