NCT03068416

Brief Summary

Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2017

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

February 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

3.9 years

First QC Date

February 21, 2017

Last Update Submit

October 14, 2021

Conditions

B-cell LeukemiaB-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    24 months

Secondary Outcomes (5)

  • Tumor response

    24 months.

  • B cell levels

    24 months

  • CAR T cell persistence

    24 months

  • Immunological profile

    24 months

  • Cytokine profile

    24 months

Study Arms (1)

CAR T cells

EXPERIMENTAL

Autologous 3rd generation CD19-targeting CAR T cells

Biological: CAR T cells

Interventions

CAR T cellsBIOLOGICAL

Autologous CD19-targeting, 3rd generation CAR T cells

CAR T cells

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory CD19+ B-cell lymphoma or leukemia with no other curative treatment option available.
  • Measurable disease.
  • All ages
  • Performance status ECOG 0-2.
  • 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 to perform the treatment.
  • Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest.
  • Pregnancy
  • Patients that do not consent to that tissue and blood samples are stored in a biobank
  • Patients whose cells cannot be manufactured.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Dept of Oncology

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • Saren T, Ramachandran M, Gammelgard G, Lovgren T, Mirabello C, Bjorklund AK, Wikstrom K, Hashemi J, Freyhult E, Ahlstrom H, Amini RM, Hagberg H, Loskog A, Enblad G, Essand M. Single-Cell RNA Analysis Reveals Cell-Intrinsic Functions of CAR T Cells Correlating with Response in a Phase II Study of Lymphoma Patients. Clin Cancer Res. 2023 Oct 13;29(20):4139-4152. doi: 10.1158/1078-0432.CCR-23-0178.

    PMID: 37540566DERIVED

MeSH Terms

Conditions

Leukemia, B-CellLymphoma, B-Cell

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Gunilla Enblad, MD, PhD

    Uppsala University Hospital, Dept of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 1, 2017

Study Start

September 18, 2017

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

SE(1)