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

Phase 1

Completed

• Conditions: B Cell Lymphoma; B Cell Leukemia
• Interventions: Biological: Autologous 3rd generation CD19-targeting CAR T cells

• Registration Number: NCT02132624
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR T cells	Autologous 3rd generation CD19-targeting CAR T cells	Autologous 3rd generation CD19-targeting CAR T cells

Primary Outcome Measures

Name	Time	Method
CAR T cell persistence	At week 1 and 5, there after every 3 months post treatment up to 24 months	Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.

Secondary Outcome Measures

Name	Time	Method
Tumor load	Every 3 months post treatment up to 24 months	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Trial Locations

Locations (1)

Uppsala University Hospital, Dept of Oncology; 🇸🇪 Uppsala, Sweden