Trials / Active Not Recruiting
Active Not RecruitingNCT04088864
CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 1 Year – 30 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and lymphoma). Another purpose of this study is to test the safety and cancer killing ability of a cell therapy against a new cancer target (CD22).
Detailed description
PRIMARY OBJECTIVE: * Determine the feasibility of manufacturing CD22 CAR T cells for administration to children and young adults with relapsed/refractory (R/R) CD22 expressing B-cell ALL or lymphoma using the Miltenyi CliniMACS Prodigy system. * Determine the safety of an established dose of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies. SECONDARY OBJECTIVE: \- Assess the clinical activity of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies, including overall survival (OS) and progression free survival (PFS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | Fludarabine is a purine antagonist antimetabolite |
| DRUG | Cyclophosphamide | Cyclophosphamide is a nitrogen mustard derivative alkylating agent |
| DRUG | Autologous CD22 CAR T | Autologous T cells transduced with lentiviral vector (m971BBZ) Chimeric Antigen Receptor (CD22 CAR) |
Timeline
- Start date
- 2020-01-10
- Primary completion
- 2023-10-31
- Completion
- 2036-09-10
- First posted
- 2019-09-13
- Last updated
- 2025-03-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04088864. Inclusion in this directory is not an endorsement.