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 |
|---|---|
| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD38 positive relapsed or refractory acute leukemia | Experimental | Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5- 10)x10^6 CD7 CAR-T cells/kg](streamdown:incomplete-link) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humanized CD7 CAR-T cells | Biological | Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5-10)x10^6 CD7 CAR-T cells/kg](streamdown:incomplete-link) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaowen tang, Ph.D | Contact | (0086)51267781856 | xwtang1020@163.com | |
| Lin Yang, Ph.D | Contact | (0086)18896802149 | ylyh188@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xiaowen tang, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | (Select) | 215000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36175988 | Derived | Cao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D015456 | Leukemia, Biphenotypic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| Cumulative incidence of relapse(CIR) | time from the date of achievement of a remission until the date of relapse. | 2 years |
| the duration of CAR T-cells in vivo | the time of CAR-T cells' persistence in blood and the copies of CAR-T cells | 2 years |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D007951 | Leukemia, Myeloid |