Trials / Recruiting
RecruitingNCT06777979
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- St. Jude Children's Research Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | IV |
| DRUG | Cyclophosphamide | IV |
| DRUG | Mesna | IV |
| DEVICE | CD19-CD22 CAR T cell infusion | CAR T cell infusion will be given intravenously, either centrally or peripherally. |
Timeline
- Start date
- 2025-04-28
- Primary completion
- 2030-01-01
- Completion
- 2031-01-01
- First posted
- 2025-01-16
- Last updated
- 2025-12-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06777979. Inclusion in this directory is not an endorsement.