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

May 18, 2026 updated by: St. Jude Children's Research Hospital

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion. CAR T cell dose will be determined by the protocol-defined dose escalation scheme, based on the number of CAR+ T cells and participant weight.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Collection and Manufacturing Eligibility

Inclusion Criteria:

  • Age <21 years old

  • Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:

    *CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy

    • 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

Exclusion Criteria:

  • Known primary immunodeficiency
  • Known HIV positivity
  • Known contraindication to receiving protocol defined lymphodepleting
  • chemotherapy regimen
  • History of hypersensitivity reaction to murine protein-containing products

Treatment Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD19-CD22-CAR T cell therapy

This study has two parts:

Collection and Manufacturing Phase - Patients will have white blood cells collected in the St. Jude Blood Donor Center through a procedure called apheresis, or your doctors may use a previously collected frozen product. The collected cells will be engineered to improve their ability to recognize and kill cancer cells. The final cell product is referred to as the CD19-CD22 CAR T cells.

Treatment Phase - Eligible patients will receive chemotherapy before receiving the CAR T cells.
Drug: Cyclophosphamide
IV
Drug: Fludarabine
IV
Drug: Mesna
IV
Device: CD19-CD22 CAR T cell infusion
CAR T cell infusion will be given intravenously, either centrally or peripherally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells
Time Frame: up 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).
up to 4 weeks after CD19-CD22-CAR T-cell infusion
Incidence of adverse events
Time Frame: up 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.
up to 4 weeks after CD19-CD22-CAR T-cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Rebecca Epperly, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1922CAR
  • NCI-2024-10103 (Other Identifier: NCI Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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