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Article ; Online: Impact of Rituximab and Host/Donor Fc Receptor Polymorphisms after Allogeneic Hematopoietic Cell Transplantation for CD20

Granot, Noa / Rezvani, Andrew R / Pender, Barbara S / Storer, Barry E / Sandmaier, Brenda M / Storb, Rainer / Maloney, David G

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2020 Volume 26, Issue 10, Page(s) 1811–1818

Abstract: We previously reported a 24% 1-year relapse rate in 93 older or medically unfit patients with ... ...

Abstract	We previously reported a 24% 1-year relapse rate in 93 older or medically unfit patients with CD20
MeSH term(s)	B-Lymphocytes ; Graft vs Host Disease/prevention & control ; Hematopoietic Stem Cell Transplantation ; Humans ; Neoplasm Recurrence, Local ; Prospective Studies ; Receptors, Fc/genetics ; Rituximab/therapeutic use ; Transplantation Conditioning ; Transplantation, Homologous
Chemical Substances	Receptors, Fc ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2020-07-18
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2020.07.014
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Zs.A 5082: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Timing of anti-PD-L1 antibody initiation affects efficacy/toxicity of CD19 CAR T-cell therapy for large B-cell lymphoma.

Blood advances

2023 Volume 8, Issue 2, Page(s) 453–467

Abstract: Abstract: More than half of the patients treated with CD19-targeted chimeric antigen receptor (CAR) T-cell immunotherapy for large B-cell lymphoma (LBCL) do not achieve durable remission, which may be partly due to PD-1/PD-L1-associated CAR T-cell ... ...

Abstract	Abstract: More than half of the patients treated with CD19-targeted chimeric antigen receptor (CAR) T-cell immunotherapy for large B-cell lymphoma (LBCL) do not achieve durable remission, which may be partly due to PD-1/PD-L1-associated CAR T-cell dysfunction. We report data from a phase 1 clinical trial (NCT02706405), in which adults with LBCL were treated with autologous CD19 CAR T cells (JCAR014) combined with escalating doses of the anti-PD-L1 monoclonal antibody, durvalumab, starting either before or after CAR T-cell infusion. The addition of durvalumab to JCAR014 was safe and not associated with increased autoimmune or immune effector cell-associated toxicities. Patients who started durvalumab before JCAR014 infusion had later onset and shorter duration of cytokine release syndrome and inferior efficacy, which was associated with slower accumulation of CAR T cells and lower concentrations of inflammatory cytokines in the blood. Initiation of durvalumab before JCAR014 infusion resulted in an early increase in soluble PD-L1 (sPD-L1) levels that coincided with the timing of maximal CAR T-cell accumulation in the blood. In vitro, sPD-L1 induced dose-dependent suppression of CAR T-cell effector function, which could contribute to inferior efficacy observed in patients who received durvalumab before JCAR014. Despite the lack of efficacy improvement and similar CAR T-cell kinetics early after infusion, ongoing durvalumab therapy after JCAR014 was associated with re-expansion of CAR T cells in the blood, late regression of CD19+ and CD19- tumors, and enhanced duration of response. Our results indicate that the timing of initiation of PD-L1 blockade is a key variable that affects outcomes after CD19 CAR T-cell immunotherapy for adults with LBCL.
MeSH term(s)	Adult ; Humans ; B7-H1 Antigen ; Cytokine Release Syndrome/etiology ; Immunotherapy ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Lymphoma, Large B-Cell, Diffuse/therapy ; Lymphoma, Large B-Cell, Diffuse/etiology
Chemical Substances	B7-H1 Antigen
Language	English
Publishing date	2023-10-30
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2023011287
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Article ; Online: High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy.

Hirayama, Alexandre V / Gauthier, Jordan / Hay, Kevin A / Voutsinas, Jenna M / Wu, Qian / Pender, Barbara S / Hawkins, Reed M / Vakil, Aesha / Steinmetz, Rachel N / Riddell, Stanley R / Maloney, David G / Turtle, Cameron J

Blood

2019 Volume 134, Issue 7, Page(s) 636–640

Abstract: Patients with follicular lymphoma (FL) with early relapse after initial chemoimmunotherapy, refractory disease, or histologic transformation (tFL) have limited progression-free and overall survival. We report efficacy and long-term follow-up of 21 ... ...

Abstract	Patients with follicular lymphoma (FL) with early relapse after initial chemoimmunotherapy, refractory disease, or histologic transformation (tFL) have limited progression-free and overall survival. We report efficacy and long-term follow-up of 21 patients with relapsed/refractory (R/R) FL (n = 8) and tFL (n = 13) treated on a phase 1/2 clinical trial with cyclophosphamide and fludarabine lymphodepletion followed by infusion of 2 × 106 CD19-directed chimeric antigen receptor-modified T (CAR-T) cells per kilogram. The complete remission (CR) rates by the Lugano criteria were 88% and 46% for patients with FL and tFL, respectively. All patients with FL who achieved CR remained in remission at a median follow-up of 24 months. The median duration of response for patients with tFL was 10.2 months at a median follow-up of 38 months. Cytokine release syndrome occurred in 50% and 39%, and neurotoxicity in 50% and 23% of patients with FL and tFL, respectively, with no severe adverse events (grade ≥3). No significant differences in CAR-T cell in vivo expansion/persistence were observed between FL and tFL patients. CD19 CAR-T cell immunotherapy is highly effective in adults with clinically aggressive R/R FL with or without transformation, with durable remission in a high proportion of FL patients. This trial was registered at clinicaltrials.gov as #NCT01865617.
MeSH term(s)	Aged ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Immunotherapy, Adoptive/methods ; Lymphocyte Depletion/methods ; Lymphoma, Follicular/therapy ; Male ; Middle Aged ; Receptors, Antigen, T-Cell/therapeutic use ; Remission Induction
Chemical Substances	CD19-specific chimeric antigen receptor ; Receptors, Antigen, T-Cell
Language	English
Publishing date	2019-08-24
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2019000905
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Article ; Online: Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure.

Gauthier, Jordan / Hirayama, Alexandre V / Purushe, Janaki / Hay, Kevin A / Lymp, James / Li, Daniel H / Yeung, Cecilia C S / Sheih, Alyssa / Pender, Barbara S / Hawkins, Reed M / Vakil, Aesha / Phi, Tinh-Doan / Steinmetz, Rachel N / Shadman, Mazyar / Riddell, Stanley R / Maloney, David G / Turtle, Cameron J

Blood

2020 Volume 135, Issue 19, Page(s) 1650–1660

Abstract: We previously reported durable responses in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) patients treated with CD19-targeted chimeric antigen receptor-engineered (CD19 CAR) T-cell immunotherapy after ibrutinib failure. Because ... ...

Abstract	We previously reported durable responses in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) patients treated with CD19-targeted chimeric antigen receptor-engineered (CD19 CAR) T-cell immunotherapy after ibrutinib failure. Because preclinical studies showed that ibrutinib could improve CAR T cell-antitumor efficacy and reduce cytokine release syndrome (CRS), we conducted a pilot study to evaluate the safety and feasibility of administering ibrutinib concurrently with CD19 CAR T-cell immunotherapy. Nineteen CLL patients were included. The median number of prior therapies was 5, and 17 patients (89%) had high-risk cytogenetics (17p deletion and/or complex karyotype). Ibrutinib was scheduled to begin ≥2 weeks before leukapheresis and continue for ≥3 months after CAR T-cell infusion. CD19 CAR T-cell therapy with concurrent ibrutinib was well tolerated; 13 patients (68%) received ibrutinib as planned without dose reduction. The 4-week overall response rate using 2018 International Workshop on CLL (iwCLL) criteria was 83%, and 61% achieved a minimal residual disease (MRD)-negative marrow response by IGH sequencing. In this subset, the 1-year overall survival and progression-free survival (PFS) probabilities were 86% and 59%, respectively. Compared with CLL patients treated with CAR T cells without ibrutinib, CAR T cells with concurrent ibrutinib were associated with lower CRS severity and lower serum concentrations of CRS-associated cytokines, despite equivalent in vivo CAR T-cell expansion. The 1-year PFS probabilities in all evaluable patients were 38% and 50% after CD19 CAR T-cell therapy, with and without concurrent ibrutinib, respectively (P = .91). CD19 CAR T cells with concurrent ibrutinib for R/R CLL were well tolerated, with low CRS severity, and led to high rates of MRD-negative response by IGH sequencing.
MeSH term(s)	Adenine/analogs & derivatives ; Adenine/therapeutic use ; Adult ; Aged ; Antigens, CD19/immunology ; Combined Modality Therapy ; Drug Resistance, Neoplasm ; Feasibility Studies ; Female ; Follow-Up Studies ; Humans ; Immunotherapy, Adoptive/methods ; Leukemia, Lymphocytic, Chronic, B-Cell/immunology ; Leukemia, Lymphocytic, Chronic, B-Cell/pathology ; Leukemia, Lymphocytic, Chronic, B-Cell/therapy ; Male ; Middle Aged ; Piperidines/therapeutic use ; Prognosis ; Receptors, Antigen, T-Cell/immunology ; Retrospective Studies ; Salvage Therapy
Chemical Substances	Antigens, CD19 ; Piperidines ; Receptors, Antigen, T-Cell ; ibrutinib (1X70OSD4VX) ; Adenine (JAC85A2161)
Language	English
Publishing date	2020-02-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2019002936
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Article ; Online: Factors associated with durable EFS in adult B-cell ALL patients achieving MRD-negative CR after CD19 CAR T-cell therapy.

Hay, Kevin A / Gauthier, Jordan / Hirayama, Alexandre V / Voutsinas, Jenna M / Wu, Qian / Li, Daniel / Gooley, Ted A / Cherian, Sindhu / Chen, Xueyan / Pender, Barbara S / Hawkins, Reed M / Vakil, Aesha / Steinmetz, Rachel N / Schoch, Gary / Chapuis, Aude G / Till, Brian G / Kiem, Hans-Peter / Ramos, Jorge D / Shadman, Mazyar /

Cassaday, Ryan D / Acharya, Utkarsh H / Riddell, Stanley R / Maloney, David G / Turtle, Cameron J

Blood

2019 Volume 133, Issue 15, Page(s) 1652–1663

Abstract: Autologous T cells engineered to express a CD19-specific chimeric antigen receptor (CAR) have produced impressive minimal residual disease-negative (MRD-negative) complete remission (CR) rates in patients with relapsed/refractory B-cell acute ... ...

Abstract	Autologous T cells engineered to express a CD19-specific chimeric antigen receptor (CAR) have produced impressive minimal residual disease-negative (MRD-negative) complete remission (CR) rates in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). However, the factors associated with durable remissions after CAR T-cell therapy have not been fully elucidated. We studied patients with relapsed/refractory B-ALL enrolled in a phase 1/2 clinical trial evaluating lymphodepletion chemotherapy followed by CD19 CAR T-cell therapy at our institution. Forty-five (85%) of 53 patients who received CD19 CAR T-cell therapy and were evaluable for response achieved MRD-negative CR by high-resolution flow cytometry. With a median follow-up of 30.9 months, event-free survival (EFS) and overall survival (OS) were significantly better in the patients who achieved MRD-negative CR compared with those who did not (median EFS, 7.6 vs 0.8 months;
MeSH term(s)	Adult ; Antigens, CD19/immunology ; Disease-Free Survival ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Immunotherapy, Adoptive/methods ; Lymphocyte Depletion ; Male ; Middle Aged ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/mortality ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/therapy ; Receptors, Chimeric Antigen ; Remission Induction/methods ; Salvage Therapy/methods ; Young Adult
Chemical Substances	Antigens, CD19 ; Receptors, Chimeric Antigen
Language	English
Publishing date	2019-02-06
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2018-11-883710
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Article ; Online: Factors associated with outcomes after a second CD19-targeted CAR T-cell infusion for refractory B-cell malignancies.

Gauthier, Jordan / Bezerra, Evandro D / Hirayama, Alexandre V / Fiorenza, Salvatore / Sheih, Alyssa / Chou, Cassie K / Kimble, Erik L / Pender, Barbara S / Hawkins, Reed M / Vakil, Aesha / Phi, Tinh-Doan / Steinmetz, Rachel N / Jamieson, Abby W / Bar, Merav / Cassaday, Ryan D / Chapuis, Aude G / Cowan, Andrew J / Green, Damian J / Kiem, Hans-Peter /

Milano, Filippo / Shadman, Mazyar / Till, Brian G / Riddell, Stanley R / Maloney, David G / Turtle, Cameron J

Blood

2020 Volume 137, Issue 3, Page(s) 323–335

Abstract: CD19-targeted chimeric antigen receptor-engineered (CD19 CAR) T-cell therapy has shown significant efficacy for relapsed or refractory (R/R) B-cell malignancies. Yet, CD19 CAR T cells fail to induce durable responses in most patients. Second infusions of ...

Abstract	CD19-targeted chimeric antigen receptor-engineered (CD19 CAR) T-cell therapy has shown significant efficacy for relapsed or refractory (R/R) B-cell malignancies. Yet, CD19 CAR T cells fail to induce durable responses in most patients. Second infusions of CD19 CAR T cells (CART2) have been considered as a possible approach to improve outcomes. We analyzed data from 44 patients with R/R B-cell malignancies (acute lymphoblastic leukemia [ALL], n = 14; chronic lymphocytic leukemia [CLL], n = 9; non-Hodgkin lymphoma [NHL], n = 21) who received CART2 on a phase 1/2 trial (NCT01865617) at our institution. Despite a CART2 dose increase in 82% of patients, we observed a low incidence of severe toxicity after CART2 (grade ≥3 cytokine release syndrome, 9%; grade ≥3 neurotoxicity, 11%). After CART2, complete response (CR) was achieved in 22% of CLL, 19% of NHL, and 21% of ALL patients. The median durations of response after CART2 in CLL, NHL, and ALL patients were 33, 6, and 4 months, respectively. Addition of fludarabine to cyclophosphamide-based lymphodepletion before the first CAR T-cell infusion (CART1) and an increase in the CART2 dose compared with CART1 were independently associated with higher overall response rates and longer progression-free survival after CART2. We observed durable CAR T-cell persistence after CART2 in patients who received cyclophosphamide and fludarabine (Cy-Flu) lymphodepletion before CART1 and a higher CART2 compared with CART1 cell dose. The identification of 2 modifiable pretreatment factors independently associated with better outcomes after CART2 suggests strategies to improve in vivo CAR T-cell kinetics and responses after repeat CAR T-cell infusions, and has implications for the design of trials of novel CAR T-cell products after failure of prior CAR T-cell immunotherapies.
MeSH term(s)	Adult ; Aged ; Antigens, CD19/metabolism ; Cell Proliferation ; Cyclophosphamide/therapeutic use ; Cytokine Release Syndrome/complications ; Female ; Humans ; Immunotherapy, Adoptive ; Leukemia, B-Cell/immunology ; Leukemia, B-Cell/therapy ; Leukemia, Lymphocytic, Chronic, B-Cell/immunology ; Leukemia, Lymphocytic, Chronic, B-Cell/therapy ; Lymphoma, Non-Hodgkin/immunology ; Lymphoma, Non-Hodgkin/therapy ; Male ; Middle Aged ; Multivariate Analysis ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/immunology ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy ; Progression-Free Survival ; T-Lymphocytes/immunology ; Treatment Outcome ; Vidarabine/analogs & derivatives ; Vidarabine/therapeutic use
Chemical Substances	Antigens, CD19 ; Cyclophosphamide (8N3DW7272P) ; Vidarabine (FA2DM6879K) ; fludarabine (P2K93U8740)
Language	English
Publishing date	2020-09-25
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2020006770
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Article ; Online: The response to lymphodepletion impacts PFS in patients with aggressive non-Hodgkin lymphoma treated with CD19 CAR T cells.

Hirayama, Alexandre V / Gauthier, Jordan / Hay, Kevin A / Voutsinas, Jenna M / Wu, Qian / Gooley, Ted / Li, Daniel / Cherian, Sindhu / Chen, Xueyan / Pender, Barbara S / Hawkins, Reed M / Vakil, Aesha / Steinmetz, Rachel N / Acharya, Utkarsh H / Cassaday, Ryan D / Chapuis, Aude G / Dhawale, Tejaswini M / Hendrie, Paul C / Kiem, Hans-Peter /

Lynch, Ryan C / Ramos, Jorge / Shadman, Mazyar / Till, Brian G / Riddell, Stanley R / Maloney, David G / Turtle, Cameron J

Blood

2019 Volume 133, Issue 17, Page(s) 1876–1887

Abstract: Factors associated with durable remission after CD19 chimeric antigen receptor (CAR)-modified T-cell immunotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) have not been identified. We report multivariable analyses of factors affecting response ... ...

Abstract	Factors associated with durable remission after CD19 chimeric antigen receptor (CAR)-modified T-cell immunotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) have not been identified. We report multivariable analyses of factors affecting response and progression-free survival (PFS) in patients with aggressive NHL treated with cyclophosphamide and fludarabine lymphodepletion followed by 2 × 10
MeSH term(s)	Antigens, CD19/immunology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cell- and Tissue-Based Therapy/methods ; Combined Modality Therapy ; Cyclophosphamide/administration & dosage ; Female ; Follow-Up Studies ; Humans ; Immunotherapy/methods ; Lymphocyte Depletion/methods ; Lymphoma, Non-Hodgkin/immunology ; Lymphoma, Non-Hodgkin/mortality ; Lymphoma, Non-Hodgkin/pathology ; Lymphoma, Non-Hodgkin/therapy ; Male ; Middle Aged ; Prognosis ; Receptors, Antigen, T-Cell/immunology ; Survival Rate ; Vidarabine/administration & dosage ; Vidarabine/analogs & derivatives
Chemical Substances	Antigens, CD19 ; Receptors, Antigen, T-Cell ; Cyclophosphamide (8N3DW7272P) ; Vidarabine (FA2DM6879K) ; fludarabine (P2K93U8740)
Language	English
Publishing date	2019-02-19
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2018-11-887067
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Impact of Rituximab and Host/Donor Fc Receptor Polymorphisms after Allogeneic Hematopoietic Cell Transplantation for CD20

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Article ; Online: Timing of anti-PD-L1 antibody initiation affects efficacy/toxicity of CD19 CAR T-cell therapy for large B-cell lymphoma.

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Article ; Online: High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy.

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Article ; Online: Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure.

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Article ; Online: Factors associated with durable EFS in adult B-cell ALL patients achieving MRD-negative CR after CD19 CAR T-cell therapy.

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Article ; Online: Factors associated with outcomes after a second CD19-targeted CAR T-cell infusion for refractory B-cell malignancies.

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Article ; Online: The response to lymphodepletion impacts PFS in patients with aggressive non-Hodgkin lymphoma treated with CD19 CAR T cells.

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