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Clinical Trial Summary

T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor prognosis. Currently, patients with relapsed/refractory type (the name given to cancer that reappears or grows again after a period of no changes or signs of cancer) of this leukaemia or lymphoma have limited choices for treatment. CAR-T cells are immune cells that are engineered to target specific cell markers. For example, CAR-T cells targeting the marker CD19 have shown great effectiveness in the treatment of B cell tumors that carry this marker. Here investigators construct a new universal CAR-T design targeting CD7 which is found on the cells of relapsed/refractory type T cell leukaemia and lymphoma and hope to test its safety and efficiency in the treatment of relapsed/refractory type T cell leukaemia and lymphoma.

Clinical Trial Description

Who can participate? Patients diagnosed with relapsed/refractory T cell leukaemia or lymphoma. Both genders, aged 2-25 years old. What does the study involve? Enrolled participants are randomly chosen to receive one of three different dose levels of CAR-T cells. 1. Dose level one: 0.6×10^7 cells/kg; 2. Dose level two: 1×10^7 cells/kg; 3. Dose level three: 1.5×10^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy including several chemotherapy agents or other interventions that are required to help the effect of the CAR-T cells. After completion of preconditioning therapy, infusion of the CAR-T cells via a tube into the vein needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins. All participants will have a blood test before infusion and at 4, 7, 10 and 14 days following infusion to measure their response to the treatment and some further tests will be required in some participants. What are the possible benefits and risks of participating? The universal CAR-T cells targeting CD7 may lead to durable disease control and long term survival. The main risks of participating include cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS). Where is the study run from? Haematology department of 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (China). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04860817
Study type Interventional
Source 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Contact Sanbin Wang, Doctor
Phone (+86)13187424131
Email [email protected]
Status Not yet recruiting
Phase Early Phase 1
Start date May 1, 2021
Completion date November 1, 2023

See also
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Completed NCT01950286 - Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. N/A
Completed NCT02518113 - A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL Phase 1/Phase 2
Recruiting NCT03081910 - Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen Phase 1
Recruiting NCT04594135 - Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies Phase 1