CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
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| ClinicalTrials.gov Identifier: NCT02132624 |
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Recruitment Status :
Completed
First Posted : May 7, 2014
Last Update Posted : October 30, 2017
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Sponsor:
Uppsala University
Collaborators:
Uppsala University Hospital
Karolinska University Hospital
AFA Insurance
Swedish Cancer Society
Information provided by (Responsible Party):
Uppsala University
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | May 5, 2014 | |||||||||
| First Posted Date ICMJE | May 7, 2014 | |||||||||
| Last Update Posted Date | October 30, 2017 | |||||||||
| Study Start Date ICMJE | April 2014 | |||||||||
| Actual Primary Completion Date | May 31, 2017 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
CAR T cell persistence [ Time Frame: At week 1 and 5, there after every 3 months post treatment up to 24 months ] Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
Tumor load [ Time Frame: Every 3 months post treatment up to 24 months ] Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
B cell number and immunoglobulins [ Time Frame: Weekly for 5 weeks, then every 3 months post treatment up to 24 months ] Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics
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| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial. | |||||||||
| Official Title ICMJE | CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial. | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Biological: Autologous 3rd generation CD19-targeting CAR T cells
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
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| Study Arms ICMJE | Experimental: CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
Intervention: Biological: Autologous 3rd generation CD19-targeting CAR T cells
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
15 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | May 31, 2017 | |||||||||
| Actual Primary Completion Date | May 31, 2017 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Sweden | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02132624 | |||||||||
| Other Study ID Numbers ICMJE | 003:TCELL 2013-001393-19 ( EudraCT Number ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Uppsala University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Uppsala University | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Uppsala University | |||||||||
| Verification Date | October 2017 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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