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Objectives:
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
A total of 20 patients may be enrolled over a period of 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HerinCAR-PD1 cells | Experimental | Patients will receive 3 cycles of HerinCAR-PD1 cells treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HerinCAR-PD1 cells | Biological | herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 2 years | |
| Disease control rate,(DCR) | 2 years | |
| Overall survival | 2 years | |
| Progress-free survival(PFS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Questionnaire will be used. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naiyan Han | Contact | +86 21 6023 6666 | naiyan.han@simcgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Naiyan Han | Shanghai International Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai International Medical Center | Recruiting | Shanghai | Shanghai Municipality | 201318 | China |
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