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

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Disease Information

Descriptive Information
Brief Title † CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy
Official Title † CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy - a Phase II Trial.
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.
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.
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Safety
Secondary Outcome Measure † Tumor response
Condition † B-cell Leukemia B-Cell Lymphoma
Intervention † BiologicalCAR T cells
Study Arms / Comparison Groups CAR T cells Autologous 3rd generation CD19-targeting CAR T cells
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 15
Start Date † April 2017
Completion Date April 2019
Primary Completion Date April 2019
Eligibility Criteria † 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.
Gender All
Ages N/A - 100 Years
Accepts Healthy Volunteers No
Contacts †† Gunilla Enblad, MD, PhD, +46 18 611 02 03, gunilla.enblad@igp.uu.se
Location Countries † Sweden
Administrative Information
NCT ID † NCT03068416
Organization ID 004:TCELL
Secondary IDs †† 2016-004043-36
Responsible Party Sponsor
Study Sponsor † Uppsala University
Collaborators †† Uppsala University Hospital
Investigators † Principal Investigator: Gunilla Enblad, MD, PhD, Uppsala University Hospital, Dept of Oncology
Information Provided By
Verification Date March 2017
First Received Date † February 21, 2017
Last Updated Date March 2, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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