Trials / Unknown
UnknownNCT03263208
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Henan Cancer Hospital · Other Government
- Sex
- All
- Age
- 2 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.
Detailed description
Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects. Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T. Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4). |
| DRUG | Fludarabine | Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3). |
| BIOLOGICAL | CD19 CAR-T | CD19 CAR-T cells will be administered after completion of the chemotherapy. |
Timeline
- Start date
- 2017-08-16
- Primary completion
- 2019-01-01
- Completion
- 2019-07-01
- First posted
- 2017-08-28
- Last updated
- 2017-10-20
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03263208. Inclusion in this directory is not an endorsement.