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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT05779930
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Acute Lymphoblastic Leukemia With Failed Remission
  • Acute Lymphoblastic Leukemia, in Relapse
  • B Cell Leukemia
  • B-cell Non Hodgkin Lymphoma
  • Non-Hodgkin's Lymphoma Refractory
  • Non-Hodgkin's Lymphoma, Relapsed

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Leukopharesis: cells collected with a target of ≥1 x10\^9 TNC with ≥3% CD3+ cells. Lymphodepleting chemotherapy: 4 days of IV chemotherapy with fludarabine and cyclophosphamide. * Fludarabine 30 mg/m2/day IV x 4 days (days -6 through -3) * Cyclophosphamide 500 mg/m2/day IV x 2 days (days -6 and-5) anti-CD19 CAR T cells: * 0.3 - 1 x 10\^6 per kilogram for patients \<50 kg * Flat dose of 0.3 - 1 x 10\^8 for patients ≥50 kg The cell infusion will take place on day 0 (at least 2 days after completion of lymphodepleting chemotherapy). The patient will receive pre-medication with acetaminophen and diphenhydramine 30-60 minutes prior to the cell infusion.

Primary Outcome Measure

Proportion of products successfully manufactured and infused with a goal of 0.3-1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3-1 x 10^8 for patients ≥50 kg [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

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By research site
Nationwide Children's Hospital· Columbus, OH

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