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The study did not initiate because manufacturing of the CAR-T product failed.
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Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.
Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell lymphoma, some patients still have primary resistance or relapse. In recent years, breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the treatment of r/r B-NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets | Experimental | Chimeric antigen receptor T cells targeting Igβ targets (CAR-T) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | DLT occurring within 28 days of the last dose. | Measured from start of treatment until 28 days after last dose |
| Adverse events profile | Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated. | Measured from start of treatment until 28 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Proportion of CR and PR subjects will be assessed at 3 months post-infusion. | up to 3 months |
| Duration of Response | Duration of overall response will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to progression, death or last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, M.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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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 |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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|
| up to 12 months |
| Progression-free survival | To measure the duration of response to chimeric antigen receptor T cells (CAR-T) targeting Igβ targets over a follow-up period of 12 months. | up to 12 months |
| Overall Survival | OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to death or last follow-up. | up to 12 months |
| Peak Plasma Concentration | the peak amplification of Igβ-CART in peripheral blood. | Measured from start of treatment until 28 days after last dose |
| Time to Peak Amplification | the time to peak amplification of Igβ-CART in peripheral blood. | Measured from start of treatment until 28 days after last dose |
| AUC0-28 | the area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion. | Measured from start of treatment until 28 days after last dose |
| PD | Pharmacodynamics is the peripheral blood B-cell ratio. | Measured from start of treatment until 28 days after last dose |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |