Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a
safety switch will be infused back to patients with B cell malignancies, including lymphoma
and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T
cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment
efficacy.
Objectives:
To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for
patients with B cell malignancies.
Eligibility:
Patients between 1 and 85 years of age, who have relapsed or refractory CD19-expressing
B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.
Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria
are eligible to participate.
Patients must have adequate organ functions.
Design:
- Peripheral blood from patients will be collected for isolation of peripheral blood
mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral
vector encoding anti-CD19 CAR containing a CD28 and a CD3 zeta as costimulatory domains
as well as a safety switch.
- Patients will receive a lymphodepleting preconditioning regimen to prepare their immune
system to accept modified T cells.
- Patients will receive an infusion of their own modified T cells. They will remain in the
hospital to be monitored for adverse events until they have recovered from the
treatment.
- Patients will have frequent follow-up visits to monitor the persistence of modified T
cells and efficacy of the treatment.
Phase:
Phase 1
Details
Lead Sponsor:
Shenzhen Second People's Hospital
Collaborator:
Shenzhen Institute for Innovation and Translational Medicine