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 2026-05-07
30
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.
CONDITIONS
Official 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 under 21 years old
- Relapsed or refractory CD19- and/or CD22-positive acute leukemia confirmed within 2 months and after any CD19 or CD22-directed therapy
- Second or greater relapse, any relapse after allogeneic hematopoietic cell transplantation (HCT), or refractory disease despite therapy
- Estimated life expectancy greater than 12 weeks for collection and manufacturing eligibility
- Karnofsky or Lansky performance score of 50 or higher
- For females of childbearing age: not lactating with intent to breastfeed, not pregnant with negative pregnancy test within 7 days prior to enrollment
- Age under 21 years old for treatment eligibility
- Detectable disease in bone marrow
- Estimated life expectancy greater than 8 weeks
- Karnofsky or Lansky performance score greater than 50
- Adequate cardiac function with left ventricular ejection fraction over 40% or shortening fraction over 25%
- Electrocardiogram without clinically significant arrhythmia
- Adequate renal function with creatinine clearance or GFR over 50 mL/min/1.73m2 (GFR over 40 mL/min/1.73m2 if under 2 years old)
- Adequate pulmonary function with forced vital capacity over 50% predicted or pulse oximetry over 92% on room air
- Total bilirubin less than 3 times upper limit of normal, except Gilbert's syndrome
- ALT or AST less than 5 times upper limit of normal
- Recovery from all grade III-IV non-hematologic acute toxicities from prior therapy
- At least 3 months from prior allogeneic HCT with no acute graft-versus-host disease and no donor lymphocyte infusion within 28 days prior to CAR T cell infusion
- For females of childbearing age: not lactating, not pregnant with negative pregnancy test within 7 days prior to enrollment, and agreement to use birth control until 3 months after infusion; male partners should use condoms
You will not qualify if you...
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to protocol-defined lymphodepleting chemotherapy
- History of hypersensitivity to murine protein-containing products
- Severe, uncontrolled bacterial, viral, or fungal infection
- Active CNS-3 disease
- Evidence of active, uncontrolled neurologic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here