Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yake Biotechnology Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-ALL/LBL | Experimental |
| |
| T-NHL | Experimental |
| |
| AML | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD7 CAR-T | Biological | Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | 28 days | |
| Treatment Emergent Adverse Event | 2 years |
Not provided
Not provided
Inclusion Criteria:
For T-ALL/LBL:
Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
For T-NHL:
Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
r/r T-NHL, and includes any of the following conditions:
According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.
For AML:
Patients is histologically diagnosed with CD7 Positive AML according to the Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) (2020. V3) by National Comprehensive Cancer Network (NCCN).
The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:
The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongxian Hu | Contact | +86-0571-87236476 | huyongxian2000@aliyun.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38657244 | Derived | Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812. | |
| 37667507 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Xu X, Zu C, Zhang M, Xiao P, Hong R, Feng J, Xu H, Cui J, Yu J, Shi J, Wei G, Chang AH, Huang H, Hu Y. HLA Fully-Mismatched Sibling-Derived CD7 CAR-T Therapy Bridging to Haploidentical Hematopoietic Stem Cell Transplantation for Hepatosplenic gammadelta T-cell Lymphoma. Cell Transplant. 2023 Jan-Dec;32:9636897231194265. doi: 10.1177/09636897231194265. |