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

NCT06777979 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 1922CARNCI-2024-10103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells

  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

  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

Study Arms (1)

CD19-CD22-CAR T cell therapy

EXPERIMENTAL

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: Fludarabine; Drug: Cyclophosphamide; Drug: Mesna; Device: CD19-CD22 CAR T cell infusion

Interventions

CD19-CD22 CAR T cell infusion DEVICE

CAR T cell infusion will be given intravenously, either centrally or peripherally.

CD19-CD22-CAR T cell therapy

Fludarabine DRUG

IV

CD19-CD22-CAR T cell therapy

Cyclophosphamide DRUG

IV

CD19-CD22-CAR T cell therapy

Mesna DRUG

IV

CD19-CD22-CAR T cell therapy

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Interventions

fludarabine; Cyclophosphamide; Mesna

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Rebecca Epperly, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Epperly, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)