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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06777979
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    IV
  • Cyclophosphamide — DRUG
    IV
  • Mesna — DRUG
    IV
  • CD19-CD22 CAR T cell infusion — DEVICE
    CAR T cell infusion will be given intravenously, either centrally or peripherally.

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
May 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Rebecca Epperly, MD
[email protected]
888-226-4343

Find similar trials in Memphis, TN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
St. Jude Children's Research Hospital· Memphis, TN

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