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This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.
The present study has 2 parts,including dose escalation and dose expansion。The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc.
Dose expansion part will be decided according to dose escalation part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation in Solid tumors and Hematologic malignancies | Experimental | In Dose Escalation part, all patients will be enrolled in different doses according to the Study Protocol for evaluate the recommend dose |
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| Dose Expansion in Solid tumors and Hematologic malignancies | Experimental | In Expansion part, all patients will be enrolled in recommended dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| engineered red blood cell | Drug | engineered red blood cell |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) in Participants in escalating part. | DLTs were assessed according to NCI-CTCAE v.5.0 during the first cycle (21 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration。 | 21 days |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for all patients. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1(only for solid tumor) or Lugano2014( only for lymphomas) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiangmin Tong, Phd | Contact | +86-13750816623 | tongxiangmin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xiangmin Tong, Phd | ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People'S Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc.
Dose expansion part will be decided according to dose escalation part.
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| per 6 weeks |
| Anti-drug antibody (ADA) | Describe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA. | 1 year |
| Maximum Concentration (Cmax) of engineered red blood cells in all Participants | Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of engineered red blood cells reached. Cmax was based on noncompartmental analysis and reported for all participants | Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15 |
| Time to Maximum Concentration (Tmax) f engineered red blood cells in all Participants | Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of engineered red blood cells reached. Tmax was based on noncompartmental analysis and reported for all participants | Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15 |