- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Clinical, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. (Pubmed Central) - Feb 25, 2018 P2 Conclusions In this global study of CAR T-cell therapy, a single infusion of tisagenlecleucel provided durable remission with long-term persistence in pediatric and young adult patients with relapsed or refractory B-cell ALL, with transient high-grade toxic effects. (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT02435849 .).
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: ELIANA: Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients (clinicaltrials.gov) - Feb 22, 2018 P2, N=81, Active, not recruiting, (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT02435849 .). Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2018 --> Jul 2018 | Trial completion date: Mar 2022 --> Nov 2021
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Clinical, Review, Journal: Building blocks for institutional preparation of CTL019 delivery. (Pubmed Central) - Feb 21, 2018 CAR T-cell therapy has been associated with adverse events (AEs) such as cytokine release syndrome, which requires rapid attention by the emergency department, intensive care unit and hospital pharmacy. In this review, we discuss several aspects of institutional preparation for leukapheresis, CAR T-cell infusion and AE management based on our experience with clinical trials of the CD19 CAR T-cell therapy CTL019.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Trial completion, Trial completion date: CART-19 for Multiple Myeloma (clinicaltrials.gov) - Feb 13, 2018 P1, N=13, Completed, In this review, we discuss several aspects of institutional preparation for leukapheresis, CAR T-cell infusion and AE management based on our experience with clinical trials of the CD19 CAR T-cell therapy CTL019. Active, not recruiting --> Completed | Trial completion date: Dec 2017 --> Jan 2018
- |||||||||| MTV273 / Novartis
Enrollment closed: CART-BCMA Cells for Multiple Myeloma (clinicaltrials.gov) - Jan 26, 2018 P1, N=25, Active, not recruiting, Trial primary completion date: Dec 2017 --> Dec 2018 Recruiting --> Active, not recruiting
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Biomarker, Preclinical, Journal, CAR T-Cell Therapy: Chimeric Antigen Receptor T Cells in Refractory B-Cell Lymphomas. (Pubmed Central) - Jan 16, 2018 P2a We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was refractory to previous treatments...Transient encephalopathy developed in approximately one in three patients and severe cytokine-release syndrome developed in one in five patients. (Funded by Novartis and others; ClinicalTrials.gov number, NCT02030834 .).
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Journal: Cellular kinetics of CTL019 in relapsed/refractory B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia. (Pubmed Central) - Dec 16, 2017 CTL019 expansion correlated with severity of cytokine release syndrome (CRS) and preinfusion tumor burden in pediatric ALL. The results described herein are the first detailed formal presentation of cellular kinetics across 2 diseases and highlight the importance of the application of in vivo cellular kinetic analyses to characterize clinical efficacy and CRS severity associated with CTL019 therapy.
- |||||||||| TmMSTN-01 / Gilead
Enrollment closed: CAR T Cells in Mesothelin Expressing Cancers (clinicaltrials.gov) - Dec 14, 2017 P1, N=30, Active, not recruiting, The results described herein are the first detailed formal presentation of cellular kinetics across 2 diseases and highlight the importance of the application of in vivo cellular kinetic analyses to characterize clinical efficacy and CRS severity associated with CTL019 therapy. Recruiting --> Active, not recruiting
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Journal: CARs on a highway with roadblocks. (Pubmed Central) - Dec 8, 2017 Active, not recruiting --> Completed | N=12 --> 4 No abstract available
- |||||||||| MTV273 / Novartis
Trial primary completion date: CART-BCMA Cells for Multiple Myeloma (clinicaltrials.gov) - Nov 30, 2017 P1, N=27, Recruiting, Trial primary completion date: Nov 2019 --> Feb 2020 Trial primary completion date: Sep 2017 --> Sep 2018
- |||||||||| birinapant (IGM-9427) / IGM Biosciences
Phase classification, Enrollment change, Trial initiation date, Trial primary completion date, Combination therapy: Birinapant and Carboplatin in Treating Patients With Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Nov 20, 2017 P1/2, N=17, Not yet recruiting, Trial primary completion date: Sep 2017 --> Sep 2018 Phase classification: P2 --> P1/2 | N=34 --> 17 | Initiation date: Jan 2017 --> Dec 2017 | Trial primary completion date: Jul 2019 --> Nov 2019
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Trial primary completion date, Minimal residual disease: CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL (clinicaltrials.gov) - Oct 26, 2017 P2, N=24, Recruiting, Phase classification: P2 --> P1/2 | N=34 --> 17 | Initiation date: Jan 2017 --> Dec 2017 | Trial primary completion date: Jul 2019 --> Nov 2019 Trial primary completion date: Apr 2018 --> Oct 2018
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Review, Journal: Chimeric Antigen Receptor T cells for B Cell Neoplasms: Choose the Right CAR for You. (Pubmed Central) - Sep 27, 2017 Several strategies are being implemented in order to solve the current open issues of CART19 therapy: (i) increasing efficacy against indolent B cell leukemias and lymphomas, (ii) avoiding or preventing antigen-loss relapses, (iii) reducing and managing toxicity, and (iv) bringing this CART therapy to routine clinical practice. The field of CART therapies is thriving, and exciting new avenues are opening for both scientists and patients.
- |||||||||| autologous redirected RNA meso-CIR T cells / University of Pennsylvania
Trial completion: Autologous Redirected RNA Meso-CIR T Cells (clinicaltrials.gov) - Sep 19, 2017 P1, N=18, Completed, N=44 --> 0 | Not yet recruiting --> Withdrawn Active, not recruiting --> Completed
- |||||||||| birinapant (IGM-9427) / IGM Biosciences
Enrollment open, Trial initiation date, Trial primary completion date: KEYNOTE 163: Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors (clinicaltrials.gov) - Aug 30, 2017 P1/2, N=104, Recruiting, Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Feb 2017 --> Aug 2017 | Trial primary completion date: Jan 2021 --> Jun 2021
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Trial primary completion date: Dose Optimization Trial of CD19 Redirected Autologous T Cells (clinicaltrials.gov) - Aug 11, 2017 P2, N=61, Active, not recruiting, Trial primary completion date: Jul 2017 --> Jun 2018 Trial primary completion date: Aug 2016 --> Oct 2018
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment open, Enrollment change, Trial primary completion date: ELIANA: Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients (clinicaltrials.gov) - Jul 26, 2017 P2, N=100, Recruiting, These results provide strong evidence for the existence of memory B-cell-independent, long-lived PCs in humans that contribute to long-lasting humoral immunity. Active, not recruiting --> Recruiting | N=72 --> 100 | Trial primary completion date: Jan 2023 --> Dec 2017
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment closed: CART-19 Post-ASCT for Multiple Myeloma (clinicaltrials.gov) - Jul 11, 2017 P2, N=25, Active, not recruiting, These findings suggest that combination of SMAC mimetics such as birinapant plus radiation may be particularly active in HNSCC, which harbor frequent FADD/BIRC2 genomic alterations. Recruiting --> Active, not recruiting
- |||||||||| MazF gene therapy / Takara
Trial primary completion date, Gene therapy, Viral vector: Redirected MazF-CD4 Autologous T Cells for HIV Gene Therapy (clinicaltrials.gov) - Jun 16, 2017 P1, N=10, Active, not recruiting, Recruiting --> Active, not recruiting | N=24 --> 30 Trial primary completion date: Mar 2017 --> Jul 2017
- |||||||||| TmMSTN-01 / Gilead
Enrollment open: CAR T Cells in Mesothelin Expressing Cancers (clinicaltrials.gov) - May 9, 2017 P1, N=30, Recruiting, Active, not recruiting --> Terminated; This study was terminated due to lack of efficacy Not yet recruiting --> Recruiting
- |||||||||| Lentiviral-based CART-meso gene therapy / University of Pennsylvania
Enrollment closed, Gene therapy: CART-meso Long-term Follow-up (clinicaltrials.gov) - Apr 25, 2017 P=N/A, N=50, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| MTV273 / Novartis
Enrollment open: CART-BCMA Cells for Multiple Myeloma (clinicaltrials.gov) - Mar 6, 2017 P1, N=27, Recruiting, Initiation date: Nov 2016 --> Mar 2017 Active, not recruiting --> Recruiting
- |||||||||| Ad-RTS-hIL-12 / Alaunos Therap, veledimex (INXN-1001) / University of Pennsylvania
Enrollment closed, IO biomarker, Metastases: A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer (clinicaltrials.gov) - Feb 14, 2017 P1/2, N=40, Active, not recruiting, Trial primary completion date: Dec 2016 --> Dec 2017 Recruiting --> Active, not recruiting
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