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| Name | Class |
|---|---|
| Yake Biotechnology Ltd. | INDUSTRY |
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This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | R/R CD7+Malignant Hematologic Diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD7 CAR-T cells injection | Drug | CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and level of AE and SAE | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after CD7 CAR T-cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| CAR-T cell expression | CAR-T cell expression in vivo | Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion |
| CAR-T related cytokine expression | CAR-T related cytokine expression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, MD | Contact | +86-0571-87236476 | hehuangyu@126.com | |
| Yongxian HU, MD | Contact | +86-0571-87236476 | huyongxian2000@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| He Huang, MD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| Allogeneic hematopoietic stem cell transplantation | Other | In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases |
|
| Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion |
| Survival Rate (SR) | Survival Rate (SR) | Evaluate at 6, 9, and 12 months |
| Time-To-Progression(TTP) | Time from the beginning of treatment to the progression of the disease | Month 2,3,4,6,12,18and 24 |
| Progression-free survival (PFS) | Assessment of PFS at Month 6,12,18and 24 | Month 6,12,18and 24 |
| Duration of remission,DOR | The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion | Up to 1 years after Treatment |
| Overall response rate,ORR | The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response). | Evaluate at 4, 8, and 12 weeks after CAR-T infusion |
| Clinical Benefit Rate(CBR) | ORR+MR | Up to 24 weeks after Treatment |
| Disease Control Rate (DCR) | CBR+SD | Up to 12 weeks after Treatment |
| Overall survival, OS | The time from CAR-T infusion to death due to any cause | Up to 1 years after Treatment |
| Minimal Residual Disease | MRD in CR and sCR patients | Up to 2 years after Treatment |
| Bone marrow transplantation STR | Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR | Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation |