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

NCT ID: NCT06777979

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2031-01-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

IV

Cyclophosphamide

Intervention Type: DRUG

IV

Mesna

Intervention Type: DRUG

IV

CD19-CD22 CAR T cell infusion

Intervention Type: DEVICE

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

Interventions

Fludarabine

IV

Intervention Type: DRUG

Cyclophosphamide

IV

Intervention Type: DRUG

Mesna

IV

Intervention Type: DRUG

CD19-CD22 CAR T cell infusion

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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 reaction to murine protein-containing products

Treatment Eligibility

• 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Epperly, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Epperly, MD

Role: CONTACT

referralinfo@stjude.org

8662785833

Facility Contacts

Rebecca Epperly, MD

Role: primary

referralinfo@stjude.org

866-278-5833

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2024-10103

Identifier Type: OTHER

Identifier Source: secondary_id

1922CAR

Identifier Type: -

Identifier Source: org_study_id