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1. Safety and Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Patients after Allogeneic HCT or CD19-based CART therapy—A Single-Center Prospective Cohort Study

Author

Ram, Ron, Hagin, David, Kikozashvilli, Nino, Freund, Tal, Amit, Odelia, Bar-On, Yael, Beyar-Katz, Ofrat, Shefer, Gabi, Moshiashvili, Miguel Morales, Karni, Chen, Gold, Ronit, Kay, Sigi, Glait-Santar, Chen, Eshel, Rinat, Perry, Chava, Avivi, Irit, Apel, Arie, Benyamini, Noam, Shasha, David, and Ben-Ami, Ronen

Published
2021
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3. P651: REAL-WORLD EFFECTIVENESS OF VENETOCLAX-BASED REGIMENS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA IN ISRAEL: UPDATE FROM THE MULTICENTER PROSPECTIVE REVEAL STUDY

Author

Herishanu, Yair, primary, Goldschmidt, Neta, additional, Itchaki, Gilad, additional, Bronstein, Yotam, additional, Levi, Itai, additional, Aviv, Ariel, additional, Fineman, Riva, additional, Dally, Najib, additional, Tadmor, Tamar, additional, Ronson, Aaron, additional, Abadi, Uri, additional, Shvidel, Levi, additional, Stemer, Galia, additional, Kay, Sigi, additional, Glait Santar, Chen, additional, Barak, Moran, additional, Rivlin, Noa, additional, Kaminsky, Natalie, additional, Cohen, Raanan, additional, Ofek, Keren, additional, Berelovich, Jenia, additional, Grunspan, Moshe, additional, and Benjamini, Ohad, additional

Published
2023
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5. Toxicity and efficacy of chimeric antigen receptor T-cell therapy in patients with diffuse large B-cell lymphoma above the age of 70 years compared to younger patients – a matched control multicenter cohort study

Author

Ram, Ron, primary, Grisariu, Sigal, additional, Shargian-Alon, Liat, additional, Amit, Odelia, additional, Bar-On, Yaeli, additional, Stepensky, Polina, additional, Yeshurun, Moshe, additional, Avni, Batia, additional, Hagin, David, additional, Perry, Chava, additional, Gurion, Ronit, additional, Sarid, Nadav, additional, Herishanu, Yair, additional, Gold, Ronit, additional, Glait-Santar, Chen, additional, Kay, Sigi, additional, and Avivi, Irit, additional

Published
2021
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6. Immunogenicity of a Third Dose of the BNT162b2 mRNA Covid-19 Vaccine in Patients with Impaired B Cell Reconstitution After Cellular Therapy—A Single Center Prospective Cohort Study

Author

Ram, Ron, Freund, Tal, Halperin, Tami, Ben-Ami, Ronen, Amit, Odelia, Bar-On, Yael, Beyar-Katz, Ofrat, Eilaty, Nili, Gold, Ronit, Kay, Sigi, Glait-Santar, Chen, and Hagin, David

Abstract

Patients with delayed B-cell reconstitution/B-cell aplasia after cellular therapy show decreased immunogenicity to the BNT162b2 mRNA COVID-19 vaccine. We prospectively evaluated both humoral and cellular immune response to a third vaccine dose in patients after allogeneic HCT (n = 10) or CD19-based chimeric antigen receptor T cells (CAR-T) therapy (n = 6) with low absolute B cell numbers and who failed to mount a humeral response after 2 vaccine doses. Humoral response was documented in 40% and 17% after allogeneic HCT and CAR-T therapy, respectively. None of the patients with complete B-cell aplasia developed anti-vaccine antibodies. Cellular response was documented in all patients after allogeneic HCT and in 83% of the patients after CAR-T. T-cell subclasses levels were not predictive for response, while a longer duration from infusion of cells was associated with a better cellular response. We conclude that cellular response develops with repeated vaccine doses even in patients with B-cell aplasia or delayed B-cell reconstitution, and these patients should therefore be vaccinated. These results should be considered in future studies analyzing immunogenicity in this population. Larger and longer follow-up studies are required to confirm whether cellular immunogenicity translates into vaccine efficacy.

Published
2022
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12. Flow Cytometry-based Detection of B-cell Lymphoproliferative Disorders in Patients with Mycosis Fungoides.

Author

GELLER, Shamir, KAY, Sigi, ELLENBOGEN, Eran, GOLDSMITH, Tomer, BAR-ON, Shoshi, WARSHAUER, Emily, DEUTSCH, Varda, SPRECHER, Eli, PERRY, Chava, and GOLDBERG, Ilan

Subjects
*LYMPHOPROLIFERATIVE disorders, *MYCOSIS fungoides, *CUTANEOUS T-cell lymphoma, *LYMPHOCYTIC leukemia, *BLOOD cell count, *CHRONIC lymphocytic leukemia, *CHRONIC leukemia
Abstract

The article presents several case studies related to flow Cytometry-based Detection of B-cell Lymphoproliferative Disorders in Patients with Mycosis Fungoides. Topics discussed a 61-year-old man was referred for evaluation of a non-pruritic rash that initially involved abdomen and later progressed to the back and limbs, and 59-year-old woman presented with a pruritic rash distributed over lateral aspects of her back and axilla with findings compatible with early-stage MF histopathologically.

Published
2020
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30. Fibronectin Enhances Ex Vivo Expansion and Maturation of Megakaryocyte Progenitors from Umbilical Cord Blood

Author

Varda Deutsch, Kay Sigi, Einav Hubel, Ariel Many, Dan Grisaru, and Elizabeth Naparstek

Subjects
Platelet Engraftment, Megakaryocyte Progenitor Cells, Immunology, Hematopoietic stem cell, Cell Biology, Hematology, Biology, Biochemistry, Andrology, Haematopoiesis, medicine.anatomical_structure, Megakaryocyte, medicine, Thrombopoiesis, Progenitor cell, Stem cell
Abstract

Following cord blood (CB) transplant and bone marrow (BM) protracted thrombocytopenia remains a serious clinical problem. Platelet production following transplant depends on the availability of adequate numbers of cytokine responsive stem and megakaryocyte progenitor cells (MK-p). Thrombopoietin (TPO), had no clinical impact on thrombopoiesis when given to patients post BMT due to the paucity of MK-p in the grafts. If expanded, Mk-p would supply the appropriate target cells to maximize the effect of TPO and provide efficient earlier platelet engraftment. We propose a novel strategy to facilitate thrombopoiesis, by expanding MK-p from CB mononuclear cells (MNC) prior to transplantation in short term cultures. While CB CD34+ cells can be expanded by several reported methods, isolation of CD34+ cells from the fresh CB is not practical due to the limited number of stem and progenitor cells in the CB units. Additionally, MK expansion from purified stem cells requires long culture periods which are inappropriate for transplantation. We aimed to improved techniques for enrichment and ex-vivo expansion of MK-p and hematopoietic stem cells, from small aliquots of whole CB, using 7–10 days cultures and new growth conditions. CB progenitors were enriched by separation of MNC from RBC on gelatin followed by centrifugation on ficoll, as we previously reported (1). MNC were expanded on fibronectin (FN) coated dishes in the presence of autologous plasma with various new cytokine combinations. These included r-hu-TPO (10 ng/ml), b- FGF (10 ng/ml), r-hu-SCF (50 ng/ml) and ARP a peptide derived from the stress variant of acetylcholinesterase (AChE-R) recently discovered to have potent hematopoietic stem cell and MK growth factor activity (2). The cell populations, MK and MK-p were characterized by high resolution flow cytometry on day 0 and 10 of culture using SSC, CD41 and CD34. True MK expansion was assessed by appropriate gating out of granulocyte and monocytes, which acquire CD41+ adherent platelets in culture. FN alone, without any other growth supplement increased the viability of cells in culture and expansion of MK-p (CD41high, SSClow and FSClow) by 2.8±1.1 (P < 0.05) fold. The combination of FN with TPO enhanced MK-p number by 4.8±2.7 and the addition of either SCF or b-FGF or ARP further stimulated the expansion of MK-p all producing about a 6 fold increase (P < 0.05). Further analysis was performed on the maturing MKs which were characterized as CD41high, CD45low/negative, CD34negative. Increased Mk ploidy was found when either b-FGF or ARP were added to cultures containing TPO, grown on FN coated plates. Significant MK maturation, as measured by GPIIb/IIIa expression using real time quantitative PCR, was also found. The combination of FN and TPO increased the MK colony forming progenitors in culture by 9 fold and up to 35 fold when other supplements were added. We demonstrate that short term expansion of enriched MK-p from a small fraction of the CB unit is feasible and easy to perform and can comply with GTP regulations. This approach may lead to the development of more effective cell therapy modalities to facilitate platelet production and decrease the time of thrombocytopenia in severely myelosuppressed patients during the extended nadir before platelet engraftment.

Published
2006

34. Toxicity and efficacy of chimeric antigen receptor T-cell therapy in patients with diffuse large B-cell lymphoma above the age of 70 years compared to younger patients - a matched control multicenter cohort study.

Author

Ram R, Grisariu S, Shargian-Alon L, Amit O, Bar-On Y, Stepensky P, Yeshurun M, Avni B, Hagin D, Perry C, Gurion R, Sarid N, Herishanu Y, Gold R, Glait-Santar C, Kay S, and Avivi I

Subjects
Aged, Antigens, CD19, Cell- and Tissue-Based Therapy, Humans, Immunotherapy, Adoptive adverse effects, Middle Aged, Receptors, Antigen, T-Cell, Lymphoma, Follicular etiology, Lymphoma, Large B-Cell, Diffuse pathology, Receptors, Chimeric Antigen
Abstract

Data regarding efficacy and toxicity of chimeric antigen receptor T (CAR-T) cell therapy in the elderly, geriatric population are insufficient. In 2019, tisagenlecleucel and axicabtagene-ciloleucel were commercially approved for relapsed/refractory diffuse large B-cell lymphoma. From May 2019 onwards, 47 relapsed/refractory diffuse large Bcell lymphoma patients, ≥70 years underwent lymphopharesis in three Israeli centers. Elderly (n=41, mean age 76.2 years) and young (n=41, mean age 55.4 years) patients were matched based on ECOG performance status and lactose dehydrogenase levels. There were no differences in CD4/CD8 ratio (P=0.94), %CD4 naive (P=0.92), %CD8 naive (P=0.44) and exhaustion markers (both HLA-DR and PD-1) between CAR-T cell products in both cohorts. Forty-one elderly patients (87%) received CAR-T cell infusion. There were no differences in the incidence of grade ≥3 cytokine-release-syndrome (P=0.29), grade≥3 neurotoxicity (P=0.54), and duration of hospitalization (P=0.55) between elderly and younger patients. There was no difference in median D7-CAR-T cell expansion (P=0.145). Response rates were similar between the two groups (complete response 46% and partial response 17% in the elderly group, P=0.337). Non-relapse mortality at 1 and 3 months was 0 in both groups. With a median follow-up of 7 months (range, 1.3-17.2 months), 6- and 12-months progression-free and overall survival in elderly patients were 39% and 32%, and 74% and 69%, respectively. EORTC QLQ-C30 questionnaires, obtained at 1 month, showed worsening of disability and cancer-related-symptoms in elderly versus younger patients. We conclude that outcomes of CAR-T cell therapy are comparable between elderly, geriatric and younger patients, indicating that age as per se should not preclude CAR-T cell administration. Longer rehabilitation therapy is essential to improve disabilities and long-term symptoms.

Published
2022
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