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CompletedNCT03068416Updated Oct 20, 2021

CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy

A Phase 2 interventional study of CAR T cells in B-cell Leukemia and B-Cell Lymphoma, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Uppsala University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
0 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

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. 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 the second infusion patients will be subjected to immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Primary outcome:

  • Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.

Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.

Secondary outcome:

Tumor response, CAR T cell persistence and immunological profile

  • Determination of tumor size and the tumor marker CD19.
  • Determination of the levels of circulating B cells.
  • Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.
  • Determination of activation markers on CAR T cells such as CD107a.
  • Determination of the presence of immunological markers in blood and biopsies.

At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.

02

Conditions studied

  • B-cell Leukemia
  • B-Cell Lymphoma
03

In context

Leukemia, B-Cell

126 studies on the registry are indexed under Leukemia, B-Cell; 46 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 110 interventional studies indexed under Leukemia, B-Cell.

Browse Leukemia, B-Cell studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Relapsed or refractory CD19+ B-cell lymphoma or leukemia with no other curative treatment option available.
  2. Measurable disease.
  3. All ages
  4. Performance status ECOG 0-2.
  5. Fertile females/males must consent to use contraceptives during participation of the trial.
  6. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
  2. Patients with primary CNS lymphoma.
  3. Known human immunodeficiency virus (HIV) infection.
  4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient to perform the treatment.
  6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest.
  7. Pregnancy
  8. Patients that do not consent to that tissue and blood samples are stored in a biobank
  9. Patients whose cells cannot be manufactured.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    CAR T cells

    Autologous 3rd generation CD19-targeting CAR T cells

    Biological: CAR T cells

Interventions

  • BiologicalCAR T cells

    Autologous CD19-targeting, 3rd generation CAR T cells

06

What researchers measure

Primary outcomes

  1. Safety

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

    Time frame: 24 months

Secondary outcomes

  1. Tumor response

    Determination of tumor size

    Time frame: 24 months.

  2. B cell levels

    Determination of circulating CD19+ B cells

    Time frame: 24 months

  3. CAR T cell persistence

    Determination of the level of CAR T cells

    Time frame: 24 months

  4. Immunological profile

    Determination of frequencies of immune cells in patient blood and tissues

    Time frame: 24 months

  5. Cytokine profile

    Determination of cytokine profile in patient blood

    Time frame: 24 months

07

Study locations

1 site
  • Uppsala University Hospital, Dept of Oncology
    Uppsala, 75185, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03068416
Lead sponsor
Uppsala University
Collaborators
Uppsala University Hospital, AFA Insurance
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Sep 18, 2017
Primary completion
Aug 19, 2021
Completion
Aug 19, 2021
Last update
Oct 20, 2021

Study contacts

Gunilla Enblad, MD, PhD
principal investigator · Uppsala University Hospital, Dept of Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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