CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.

Uppsala University

Status and phase: Completed; Phase 2; Phase 1

Conditions: B Cell Leukemia; B Cell Lymphoma

Treatments: Biological: Autologous 3rd generation CD19-targeting CAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02132624

2013-001393-19 (EudraCT Number)

003:TCELL

Details and patient eligibility

About

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. 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 retrovirus 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory CD19+ B-cell lymphoma or leukemia.
• Measurable disease.
• Performance status ECOG 0-2.
• >18 years old.
• Fertile females/males must consent to use contraceptives during participation of the trial.
• Signed informed consent.

Exclusion criteria

• Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
• Patients with primary CNS lymphoma.
• Known human immunodeficiency virus (HIV) infection.
• Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
• Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
• Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
• Patients that do not consent to that tissue and blood samples are stored in a biobank.
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

CAR T cells

Experimental group

Description:

Autologous 3rd generation CD19-targeting CAR T cells

Treatment:

Biological: Autologous 3rd generation CD19-targeting CAR T cells