CD19 CAR T-Cell Therapy for Relapsed/Refractory ALL and NHL
This study is looking at a treatment called CD19 specific Chimeric Antigen Receptor T Cell (CAR T-cell) therapy for children and young adults (up to 30 years old) with certain types of blood cancers, specifically B-cell acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin lymphoma (NHL), that have come back or haven't responded to other treatments. The CAR T-cells are made from your own immune cells and are designed to find and fight cancer cells. Researchers want to see if it's safe and possible to make and give these CAR T-cells using a special device called CliniMACS Prodigy. They will also look at how well the treatment works. The study plans to enroll 12 participants and is currently unclear on its recruitment status.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
- What's involved
- You would undergo screening, have your cells collected (leukapheresis), receive chemotherapy for four days, and then have the CD19 CAR T-cells infused between 2-14 days after chemotherapy. You will be admitted to the hospital for the chemotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to one year after the CAR T-cell infusion. The success of manufacturing and infusion will be measured at 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05779930
Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL
Not Yet Recruiting
EARLY_PHASE1Up to 30InterventionalTreatmentNationwide Children's HospitalInvestigator-initiated
~12 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:CD19 specific Chimeric Antigen Receptor T Cell
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 4 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Margaret Lamb, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.
Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age
Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening
Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.
Meets criteria for non-hematopoietic organ function:
Renal function: Estimated glomerular filtration rate ≥60 mL/min x appropriate estimation of patient's body surface area m2/1.73m2 using the modified Schwartz formula for pediatric patients and Crockcoft Gault formula for adults.
Liver function: Total bilirubin ≤ 2 mg/dl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and ALT and AST ≤ 5 x ULN for age (unless related to leukemic involvement)
Cardiac function: left ventricular ejection fraction ≥40%
Pulmonary function: minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \>91% on room air
Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator.
Signed consent by parent/guardian and assent if appropriate for subjects \< 18 years of age. Signed consent by patient/subject if ≥18 years of age.
Exclusion
Acute/ongoing neurologic toxicity \> Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 1 months.
Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment
Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening
Pregnant or nursing (lactating) women.
Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
HIV positive test within 8 weeks of screening
Allogeneic HSCT within 3 months of enrollment
Any prior CD19 CAR T cell therapy
What this trial measures
- 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 kg4 years
Reported as the proportion of products successfully manufactured and infused
- Incidence and severity of adverse eventsUp to 1 year after CAR T cell infusion
Summarized with descriptive statistics