NCT04860817

A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL

Investigating the Safety and Efficacy of Anti-CD7 CAR-T Cell Immunotherapy in Patients With Relapse and Refractory T-cell Acute Lymphoblastic Leukemia or T Lymphoblastic Lymphoma

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• T-cell Acute Lymphoblastic Leukemia
• T-lymphoblastic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Target CD7 CAR-T cells	Enrolled participants are allocated to one of three different dose levels of target CD7 CAR-T cells. The infusion dose of CAR-T cells will start at low dose and then rise to higher dose after completion of low dose group. 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 suggested as: Fludarabine 30 mg/m\^2×6d, Cyclophosphamide 300 mg/m\^2×6d or Cyclophosphamide 600 mg/m\^2×6d. After completion of preconditioning therapy, infusion of CAR-T cells needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-04-30
• Completion: 2023-11-01
• First posted: 2021-04-27
• Last updated: 2022-11-29

Locations

1 site across 1 country: China