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CD19-CD22 CAR T Cell Therapy for Pediatric ALL

This study is testing a new cell therapy called CD19-CD22 CAR T cell infusion for children and young adults (up to 21 years old) with acute lymphoblastic leukemia (ALL) that has come back or not responded to previous treatments. Before receiving the CAR T cells, participants will get chemotherapy (Fludarabine, Cyclophosphamide, and Mesna). The main goals are to find a safe dose of the CD19-CD22 CAR T cells and to understand any side effects within the first 4 weeks. Researchers will also look at how well this treatment works against the leukemia. This study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is a Phase 1 study designed to evaluate the safety of CD19-CD22 CAR T cells. It plans to enroll 30 participants.
What's involved
Treatment involves a single course of chemotherapy followed by an intravenous infusion of CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and the recommended dose for up to 4 weeks after the CAR T-cell infusion.

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NCT06777979

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

Recruiting
PHASE1Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~30 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideMesnaCD19-CD22 CAR T cell infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells
Measured over up to 4 weeks after CD19-CD22-CAR T-cell infusion
+1 more outcome measured

Conditions

Acute Lymphoblastic Leukemia
Recurrent Acute Lymphoblastic Leukemia
Recurrent B Acute Lymphoblastic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaCD19 GeneCD22 Gene

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Rebecca Epperly, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Rebecca Epperly, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \<21 years old
Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
Second or greater relapse
Any relapse after allogeneic HCT
Refractory disease (primary or in relapse) despite therapy designed to induce remission
Estimated life expectancy of \> 12 weeks
Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
For females of childbearing age:
Not lactating with intent to breastfeed
Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
Age \< 21 years old
Detectable disease in the bone marrow
Estimated life expectancy of \> 8 weeks
Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A)
Adequate cardiac function defined as left ventricular ejection fraction \>40%, or shortening fraction \> 25%
EKG without evidence of clinically significant arrhythmia
Adequate renal function defined as creatinine clearance or radioisotope GFR \>50 mL/min/1.73m2 (GFR \>40 mL/min/1.73m2 if \<2 years of age)
Adequate pulmonary function defined as forced vital capacity (FVC) \>50% of predicted value; or pulse oximetry \>92% on room air
Total bilirubin \< 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5 times the upper limit of normal for age
Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion
For females of childbearing age:
Not lactating with intent to breastfeed
Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.

Exclusion

Known primary immunodeficiency
Known HIV positivity
Known contraindication to receiving protocol defined lymphodepleting
chemotherapy regimen
History of hypersensitivity reaction to murine protein-containing products
Known primary immunodeficiency
Known HIV positivity
Known contraindication to receiving protocol defined lymphodepleting
chemotherapy regimen
History of hypersensitivity reactions to murine protein-containing products
Severe, uncontrolled bacterial, viral or fungal infection
Active CNS-3 disease
Evidence of active, uncontrolled neurologic disease

What this trial measures

  • Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cellsup to 4 weeks after CD19-CD22-CAR T-cell infusion

    Phase I design to determine the RP2D of CD19-CD22-CAR T cells. Two (2) dose levels will be evaluated (1x106 and 3x106cells/kg).

  • Incidence of adverse eventsup to 4 weeks after CD19-CD22-CAR T-cell infusion

    Will be assessed and graded using the CTCAE v5.0, with the exception of CRS and ICANS, which will be graded according to ASTCT Consensus Guidelines. Adverse events will be summarized descriptively and dose limiting toxicity (DLT) rate will be reported.