NCT02132624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

3.2 years

First QC Date

May 5, 2014

Last Update Submit

October 27, 2017

Conditions

B Cell LymphomaB Cell Leukemia

Outcome Measures

Primary Outcomes (1)

  • CAR T cell persistence

    Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.

    At week 1 and 5, there after every 3 months post treatment up to 24 months

Secondary Outcomes (1)

  • Tumor load

    Every 3 months post treatment up to 24 months

Other Outcomes (1)

  • B cell number and immunoglobulins

    Weekly for 5 weeks, then every 3 months post treatment up to 24 months

Study Arms (1)

CAR T cells

EXPERIMENTAL

Autologous 3rd generation CD19-targeting CAR T cells

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

Interventions

Autologous 3rd generation CD19-targeting CAR T cellsBIOLOGICAL

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

CAR T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Dept of Oncology

Uppsala, 75185, Sweden

Location

Related Publications (2)

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PMID: 34515338DERIVED

  • Enblad G, Karlsson H, Gammelgard G, Wenthe J, Lovgren T, Amini RM, Wikstrom KI, Essand M, Savoldo B, Hallbook H, Hoglund M, Dotti G, Brenner MK, Hagberg H, Loskog A. A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia. Clin Cancer Res. 2018 Dec 15;24(24):6185-6194. doi: 10.1158/1078-0432.CCR-18-0426. Epub 2018 Aug 10.

    PMID: 30097433DERIVED

MeSH Terms

Conditions

Lymphoma, B-CellLeukemia, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic Diseases

Study Officials

  • Angelica Loskog, PhD

    Uppsala University

    STUDY DIRECTOR

  • Gunilla Enblad, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

  • Hans Hagberg, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

April 1, 2014

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

SE(1)