The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).

Start Date27 Feb 2024

Sponsor / Collaborator

Istituto Giannina Gaslini

NCT05225363

/ RecruitingPhase 1IIT

A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer

This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.

Start Date05 May 2022

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Virus -specific T cells(Istituto Giannina Gaslini)

100 Translational Medicine associated with Virus -specific T cells(Istituto Giannina Gaslini)

100 Patents (Medical) associated with Virus -specific T cells(Istituto Giannina Gaslini)

Literatures (Medical) associated with Virus -specific T cells(Istituto Giannina Gaslini)

01 Jan 2023·Cancer Immunology, Immunotherapy

Efficacy and safety of chimeric antigen receptor T-cells treatment in central nervous system lymphoma: a PRISMA-compliant single-arm meta-analysis

Article

Author: Huo, Hongjia ; Liu, Yuanbo ; Li, Ruonan ; Lv, Liwei ; Wu, Yuchen ; Sun, Xuefei ; Deng, Zixin ; Shi, Han

BACKGROUNDChimeric antigen receptor (CAR) T cells are used to treat refractory and recurrent B-cell lymphoma. When administered intravenously, CAR T cells can be detected in cerebrospinal fluid, and thus represent a promising method for the treatment of central nervous system lymphoma (CNSL). This meta-analysis aimed to clarify the effectiveness and safety of CAR T-cell therapy in the treatment of CNSL.METHODSStudies involving patients with CNSL who received CAR T-cell therapy that reported overall response (OR), complete response (CR), and partial response (PR) were included. A random-effects or fixed-effects model with double arcsine transformation was used for the pooled analysis and 95% confidence intervals (CI) were determined for all outcomes.RESULTSEight studies, comprising 63 patients, were identified and were included in the meta-analysis. The pooled OR and CR rates after treatment with CAR T cells were 69% (95% CI, 56-81%) and 51% (95% CI, 37-64%), respectively. The pooled rate of progressive disease after remission was 38% (95% CI, 21-55%). The pooled rate for neurotoxicity grade 3 or above was 12% (95% CI, 3-24%, I² = 0.00%, p = 0.53). No treatment-related deaths were reported.CONCLUSIONSCAR T-cell therapy is a promising option for the treatment of CNSL owing to a high short-term remission rate and controllable side effects. However, the high recurrence rate after remission must be addressed. Long-term follow-up data with large sample sizes are also needed to better assess the effectiveness and safety of CAR T-cell therapy.REGISTRATIONThis meta-analysis was registered in the international prospective register of systematic reviews (PROSPERO) (CRD42022301332).

01 Sep 2018·Journal of Oncology Pharmacy PracticeQ4 · MEDICINE

A review of CD19-targeted immunotherapies for relapsed or refractory acute lymphoblastic leukemia

Q4 · MEDICINE

Review

Author: Perissinotti, Anthony J ; Marini, Bernard L ; Rudoni, Joslyn ; DasGupta, Ryan K

Aim Novel immunotherapies have generated high response rates and unique adverse effects among patients with relapsed or refractory acute lymphoblastic leukemia. Therapies engaging endogenous T-cells against acute lymphoblastic leukemia are emerging for children and adults with various poor prognostic factors, thus accurate knowledge of immunotherapies is necessary for their effective implementation in the future. In this review, we evaluate clinical trial data regarding chimeric antigen receptor T-cells and blinatumomab, for the treatment of relapsed or refractory acute lymphoblastic leukemia. Summary In the relapsed or refractory setting, response rates rapidly diminish after subsequent lines of chemotherapy and cumulative toxicities may cause significant patient harm. Immunotherapies provide an approach to improve response rates and minimize traditional toxicities via novel mechanisms of action. Two therapies targeting CD19 antigens expressed on B-cell acute lymphoblastic leukemia lineages, chimeric antigen receptor T-cells, and blinatumomab have induced complete remissions among high-risk patient populations, especially those refractory to multiple therapies. Adverse effects such as cytokine release syndrome and neurologic sequelae remain serious precautions of each therapy. Conclusion Knowledge of immunotherapy mechanisms and clinical outcomes associated with immunotherapies is critical for the optimization of treating patients with relapsed or refractory acute lymphoblastic leukemia. Future use of chimeric antigen receptor T-cells and blinatumomab demands proper assessment of a patient’s disease and treatment history in addition to unique monitoring and supportive care interventions.

HemaSphere

Hijacking the Pathway: Perspectives in the Treatment of Mature T-cell Leukemias

Author: Herling, Marco ; Wahnschaffe, Linus

The most prevalent post-thymic T-cell malignancies of primary leukemic presentation in Western countries are T-cell prolymphocytic leukemia (T-PLL) and T-cell large granular lymphocyte leukemia (T-LGL). Each, T-PLL and T-LGL, are diagnosed at incidences of approximately 1.1 per million per year in individuals of median ages of 65 and 55 years (yet with broad ranges), respectively.1–3 Both malignancies represent extremes of the spectrum of T-cell differentiation and growth kinetics, hence have “opposing” natural clinical courses. The typically CD4+ memory-type T-PLL cell is functionally inert, but highly proliferative. Exponentially increasing tumor burden involves blood, (failing) bone marrow (BM), and spleen. The median overall survival (OS) is 2–3 years. On the contrary, T-LGL cells are typically aberrant CD8+ cytotoxic T-lymphocytes that underly highly symptomatic auto-immune phenomena in an otherwise low proliferative disease (median OS ~10 years).3 Related to T-LGL is the even rarer chronic lymphoproliferative disorder of NK-cells, which too, presents with the characteristic cytopenias. The different biology and clinical presentations of T-PLL and T-LGL call for different treatment strategies with respect to targets and therapeutic intensities. In the following, we will discuss future approaches for both malignancies that are based on our current molecular disease concepts as well as on encouraging preclinical and early clinical data. Not discussed here are the other 2 forms of mature T-cell leukemias, namely the endemic adult T-cell leukemia/lymphoma and the dermotropic Sezary Syndrome. Problems with the current therapeutic approaches Common to T-PLL and T-LGL is our limited armamentarium of disease-specific therapeutics that induce clonal eradication or sustained tumor control. There is no European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA) approved drug for these indications. In T-PLL, first-line therapy should include the monoclonal CD52-antibody alemtuzumab that is available through a compassionate-use program. The initial overall response rates after alemtuzumab as a single agent or in combination with chemotherapeutics are ~90%, but all patients eventually relapse. Conventional chemotherapeutics, such as purine analogs, are second-line attempts. A consolidating allogeneic stem cell transplantation (alloHSCT) at first best response is the only current option for long-term disease control with a 3-year median OS of transplanted patients between 21% and 40%,4 but only about one third of T-PLL patients are eligible to undergo this procedure. Although the prognosis is better for T-LGL (10-y OS ~70%),3 therapeutic options in this entity have hardly changed over the past 2 decades. Besides supportive measures (eg, hematopoietic growth factors), causal therapies act anti-proliferative and immunosuppressive to alleviate cytopenias and to reduce (eg, arthritic) symptoms. A phase II comparative analysis of the first-line sequences of methotrexate followed by cyclophosphamide and vice versa characterizes our current state of innovation in T-LGL ({"type":"clinical-trial","attrs":{"text":"NCT01976182","term_id":"NCT01976182"}}NCT01976182). Commonly used second-line substances include cyclosporin A, fludarabine, or bendamustine.3 Alemtuzumab ({"type":"clinical-trial","attrs":{"text":"NCT00345345","term_id":"NCT00345345"}}NCT00345345) as well as other monoclonal antibodies (eg, siplizumab [{"type":"clinical-trial","attrs":{"text":"NCT00123942","term_id":"NCT00123942"}}NCT00123942, anti-CD2] or Mik-beta-1 [{"type":"clinical-trial","attrs":{"text":"NCT00076180","term_id":"NCT00076180"}}NCT00076180], anti-CD122) were investigated in pilot series without having shown substantial benefits thus far. Recent genetic profiling studies and their implications on deregulated molecular pathways have advanced our disease concepts of T-PLL and T-LGL. In conjunction with compound sensitivity screens, this improved biological understanding has ushered an era of intensified interrogations of pathway-specific novel substances, which are outlined here (Figures (Figures11 and and22). Open in a separate window Figure 1. Currently recognized key pathways in T-PLL and T-LGL that provide potential targets for novel treatment strategies. Illustrated are receptors and molecular signaling nodes as well as their interactions in alignment with the modes of action of most promising compound classes in the treatment of T-PLL and T-LGL. A defective response to DNA damage caused by dysfunctional ATM is a pathogenetic hallmark of T-PLL. Re-activation of p53 or downstream modification of the BCL2/MCL1 equilibrium provide reasonable approaches to restore the tumor cell’s ability to undergo intrinsic apoptosis. Further strategies aim to inhibit vital growth signals, that is, via inhibition of proliferation and differentiation signals induced by cytokine or TCR signaling. Preliminary efforts (displayed transparent) are undertaken in the field of immunotherapies: CAR-T cells targeting the TCR β-chain are under development. The use of immune checkpoint inhibitors and modulation of the non-T-immune cell synapse (eg, NK-cells, macrophages [MΦ]) is effective in other T-cell malignancies, but has thus far not been evaluated systematically in T-PLL or in T-LGL. Ac = acetylated; ADCC= antibody-dependent cell-mediated cytotoxicity; ATM = ataxia-telangiectasia mutated; BAK = BCL2 antagonist/killer; BAX = BCL2 associated X; BCL2 = B-cell lymphoma 2; CAR-T = chimeric antigen receptor T-cells; CDK = cyclin-dependent kinase; CHK2 = checkpoint kinase 2; FasR = FAS cell surface death receptor; HDAC = histone deacetylase inhibitors; ITK = IL2 inducible T-cell kinase; JAK = janus kinase; MCL1 = myeloid cell leukemia 1; MDM2 = mouse double minute 2; NK = natural killer cells; P = phosphorylated; STAT = signal transducer and activator of transcription; TCL1A = T-cell leukemia/lymphoma 1A; T-LGL = T-cell large granular lymphocyte leukemia; T-PLL = T-cell prolymphocytic leukemia; TCR = T-cell receptor.

100 Deals associated with Virus -specific T cells(Istituto Giannina Gaslini)

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Indication	Highest Phase	Country/Location	Organization	Date
Virus Diseases	Phase 1	-	Istituto Giannina Gaslini	27 Feb 2024

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