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Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM0306 | Experimental | IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM0306 | Drug | IMM0306 is an bi-specific antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity) | DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1. | End of Study (52 Weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng Huang, MD | VP，Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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