CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorSt. Jude Children's Research Hospital
About this trial
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility.
The main purpose of this study is to determine:
* Evaluate different doses of fludarabine prior CAR T cell infusion * How your body processes fludarabine and cyclophosphamide, * How long the CAR T cells last in the body, * Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and * The side effects of this therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Refractory disease (primary or in relapse)
2nd or greater relapse
Any relapse after allogeneic hematopoietic cell transplantation
1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT
Disqualifiers
Known primary immunodeficiency
History of HIV infection
Severe intercurrent bacterial, viral or fungal infection
History of hypersensitivity reactions to murine protein-containing products
Trial design
Design model
Single group
Treatments tested in this trial
Fludarabine
DrugGiven IV
Cyclophosphamide
DrugGiven IV
Mesna
DrugGiven IV
CD19-CAR T cell Infusion
Biological/VaccinePatients will receive the CD19-CAR T cells by vein, through either an IV or a central line.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: CAR19PK TherapyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Fludarabine Pharmacokinetics
Determination of Fludarabine exposure (area under the curve \[AUC\], mg-hr/L) using blood samples collected on days -5, -4 and -3
Time frame
Days -5, -4 and -3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov