Trials / Unknown
UnknownNCT02963038
CAR T Cells for Refractory B Cell Malignancy
Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd. · Industry
- Sex
- All
- Age
- 1 Year – 70 Years
- Healthy volunteers
- Not accepted
Summary
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
Detailed description
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous CD19-targeting CAR T cells | Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-06-01
- Completion
- 2021-06-01
- First posted
- 2016-11-15
- Last updated
- 2017-04-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02963038. Inclusion in this directory is not an endorsement.