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

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ClinicalTrials.gov Identifier: NCT02132624

Recruitment Status : Completed

First Posted : May 7, 2014

Last Update Posted : October 30, 2017

Sponsor:

Collaborators:

Uppsala University Hospital

Karolinska University Hospital

AFA Insurance

Swedish Cancer Society

Information provided by (Responsible Party):

Uppsala University

Tracking Information

First Submitted Date ^ICMJE

May 5, 2014

First Posted Date ^ICMJE

May 7, 2014

Last Update Posted Date

October 30, 2017

Study Start Date ^ICMJE

April 2014

Actual Primary Completion Date

May 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CAR T cell persistence [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Tumor load [ Time Frame: 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

B cell number and immunoglobulins [ Time Frame: Weekly for 5 weeks, then every 3 months post treatment up to 24 months ]

Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

B Cell Lymphoma
B Cell Leukemia

Intervention ^ICMJE

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

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Study Arms ^ICMJE

Experimental: CAR T cells

Autologous 3rd generation CD19-targeting CAR T cells

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

May 31, 2017

Actual Primary Completion Date

May 31, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Sweden

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02132624

Other Study ID Numbers ^ICMJE

003:TCELL
2013-001393-19 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Uppsala University

Study Sponsor ^ICMJE

Uppsala University

Collaborators ^ICMJE

Uppsala University Hospital
Karolinska University Hospital
AFA Insurance
Swedish Cancer Society

Investigators ^ICMJE

Study Director:	Angelica Loskog, PhD	Uppsala University
Principal Investigator:	Gunilla Enblad, MD, PhD	Uppsala University Hospital
Principal Investigator:	Hans Hagberg, MD, PhD	Uppsala University Hospital

PRS Account

Uppsala University

Verification Date

October 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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