Actively Recruiting
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called CD19-CD22-CAR T cells in patients 21 years old or younger with recurrent or refractory acute lymphoblastic leukemia that tests positive for CD19 and/or CD22. This phase I study aims to determine the safety of these engineered immune cells and find the best dose for future studies, while also assessing their ability to fight leukemia. Treatment begins with a single course of chemotherapy using fludarabine and cyclophosphamide to prepare the body, followed by an infusion of the CD19-CD22-CAR T cells. The dose of CAR T cells will be adjusted according to weight and a dose escalation plan. The study includes a collection and manufacturing phase where patient's white blood cells are collected or previously stored cells are used to create the CAR T cells designed to target leukemia. Participants will be closely monitored for safety and side effects up to four weeks after the CAR T cell infusion. Researchers will measure the recommended phase 2 dose and track any adverse events. The study involves blood tests, physical exams, and assessments of heart, kidney, and lung function, along with pregnancy tests for females of childbearing age. The total participation time varies but focuses on the period around the CAR T cell infusion and early recovery.
CONDITIONS
Brief Title
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 21 years old
- Diagnosis of relapsed or refractory CD19- and/or CD22-positive acute leukemia confirmed within 2 months after any CD19 or CD22-directed therapy
- Second or greater relapse, or any relapse after allogeneic hematopoietic cell transplantation (HCT), or refractory disease despite remission therapy
- Estimated life expectancy greater than 12 weeks (collection phase) or greater than 8 weeks (treatment phase)
- Karnofsky or Lansky performance score of 50 or higher
- For females of childbearing age: not pregnant, not lactating, with negative pregnancy test within 7 days prior to enrollment
- Detectable disease in bone marrow (treatment phase)
- Adequate heart, kidney, and lung function as defined by study requirements
- Recovery from severe acute toxicities from prior therapy
- If prior allogeneic HCT, at least 3 months since transplant with no acute graft versus host disease and no donor lymphocyte infusion within 28 days prior to CAR T cell infusion
- Agreement to use birth control for females of childbearing age and male partners until 3 months post-infusion
You will not qualify if you...
- Known primary immunodeficiency
- Known HIV positivity
- Contraindication to lymphodepleting chemotherapy regimen
- History of hypersensitivity to murine protein-containing products
- Severe, uncontrolled bacterial, viral, or fungal infection
- Active central nervous system disease classified as CNS-3
- Evidence of active, uncontrolled neurologic disease
- Pregnant or lactating females intending to breastfeed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable, based on manufacturing process
Participants undergo collection of white blood cells through apheresis or use previously collected frozen cells. These cells are engineered to create the CD19-CD22 CAR T cells.
Duration - Until completion of chemotherapy and CAR T cell infusion, typically within a few weeks
Participants receive a single course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR T cells.
1 to 2 visits for chemotherapy and CAR T cell infusion
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
R
Rebecca Epperly, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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