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

NCT ID: NCT03068416

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2021-08-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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B-cell Leukemia B-Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR T cells

Autologous 3rd generation CD19-targeting CAR T cells

Group Type EXPERIMENTAL

CAR T cells

Intervention Type BIOLOGICAL

Autologous CD19-targeting, 3rd generation CAR T cells

Interventions

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CAR T cells

Autologous CD19-targeting, 3rd generation CAR T cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

AFA Insurance

INDUSTRY

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunilla Enblad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital, Dept of Oncology

Locations

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Uppsala University Hospital, Dept of Oncology

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 37540566 (View on PubMed)

Other Identifiers

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2016-004043-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

004:TCELL

Identifier Type: -

Identifier Source: org_study_id