Recruiting
Phase 1

CAR T Cell Therapy

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06777979

Conditions

Acute Lymphoblastic Leukemia

Recurrent Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Cyclophosphamide

Mesna

CD19-CD22 CAR T cell infusion

Study Details

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

Acute Lymphoblastic Leukemia

Recurrent Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

Study ID

NCT06777979

Start date

Apr 28, 2025

Status verified date

May, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Fludarabine

IV

Cyclophosphamide

IV

Mesna

IV

CD19-CD22 CAR T cell infusion

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

Primary outcome measure

  • Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Rebecca Epperly, MD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Rebecca Epperly, MD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-19.