Trials / Not Yet Recruiting

Not Yet RecruitingNCT05779930

Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL

Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Status: Not Yet Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 12 (estimated)

Sponsor: Nationwide Children's Hospital · Academic / Other
Sex: All
Age: 30 Years
Healthy volunteers: Not accepted

Summary

This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.

Detailed description

PRIMARY OBJECTIVE: * To examine the feasibility of manufacture and administration of autologous CD19 CAR T cells at a minimum target dose of 0.3 x 10\^6 to 1 x 10\^6 per kilogram for patients \<50 kg and a flat dose of 0.3 - 1 x 10\^8 for patients ≥50 kg using the Miltenyi CliniMACS Prodigy automated T Cell Transduction (TCT) process. * To evaluate the safety of administration of CD19 CAR T cells after lymphodepletion with fludarabine and cyclophosphamide. SECONDARY OBJECTIVE: • To estimate the efficacy of CD19 specific CAR-T cells in pediatric and young adult patients with relapsed/refractory CD19+ B-cell ALL and NHL. EXPLORATORY OBJECTIVE: • To evaluate the persistence of CD19 CAR T cells after infusion. The autologous lymphocytes are collected from the patient via apheresis. The apheresis product is then transported to the on-site GMP facility for manufacture of the CAR T cell product. Patients may be admitted to begin lymphodepleting chemotherapy during the CAR T cell manufacturing process. When the CAR T cell product is ready, the cells may be administered fresh or may be cryopreserved for use at a later date depending on the patient's clinical status. All patients will be admitted to the hospital to undergo a Fludarabine/Cyclophosphamide based leukoreduction conditioning regimen to be completed 2-14 days prior to CAR T cell infusion. Patients will be admitted for a minimum of 7 days after the CAR T infusion to monitor for toxicity including cytokine release syndrome, neurologic toxicity, and tumor lysis syndrome. Lymphodepleting chemotherapy: * Fludarabine 30 mg/m2/day IV x 4 days * Cyclophosphamide 500 mg/m2/day IV x 2 days CD19 CAR T cell dose: * 0.3 x 10\^6 to 1 x 10\^6 per kilogram for patients \<50 kg * Flat dose of 0.3 - 1 x 10\^8 for patients ≥50 kg

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	CD19 specific Chimeric Antigen Receptor T Cell	Infusion of CD19 CAR-T Cells manufactured on-site using the CliniMACS Prodigy

Timeline

Start date: 2025-10-01
Primary completion: 2030-12-01
Completion: 2035-12-01
First posted: 2023-03-22
Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05779930. Inclusion in this directory is not an endorsement.