Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT05805943
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
154 participants
INTERVENTIONAL
2020-03-02
2025-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IMM0306 Monotherapy
Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level.
Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.
IMM0306
IMM0306 is an bi-specific antibody
Interventions
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IMM0306
IMM0306 is an bi-specific antibody
Eligibility Criteria
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Inclusion Criteria
* At least one measurable or assessable tumor lesion.
* Adequate organ and hematologic function.
* Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
* All adverse events from prior treatment must be CTCAE v5.0 grade \<= 1
Exclusion Criteria
* Systemic steroid therapy (dose equivalent to \> 10 mg prednisone / day).
* History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade \>=3).
* Have evidence of severe uncontrollable active infection.
* Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
18 Years
ALL
No
Sponsors
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
OTHER
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Facility Contacts
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Yuankai Shi
Role: primary
References
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Yang J, Song Y, Zhou K, Li Z, Zhang M, Jing H, Wang Z, Yu L, Meng W, Lu Q, Tian W, Shi Y. Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPalpha, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. J Hematol Oncol. 2024 Dec 18;17(1):123. doi: 10.1186/s13045-024-01646-2.
Other Identifiers
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IMM0306-I
Identifier Type: -
Identifier Source: org_study_id
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