Afami-cel (MAGE-A4)
2023
- Afamitresgene Autoleucel (Afami-cel; Formerly ADP-A2M4) Demonstrates Durable Clinical Responses by Inducing Broad Immune Engagement With Anti-Tumor Activity
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Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial.
Nat Med (2023). https://doi.org/10.1038/s41591-022-02128-z
Hong, D.S., Van Tine, B.A., Biswas, S. et al. -
The SPEARHEAD-1 Trial of Afamitresgene Autoleucel (“Afami-cel" [Formerly ADP-A2M4]): Analysis of Overall Survival in Advanced Synovial Sarcoma, B. Van Tine et al, American Society of Medical Oncology annual meeting, Chicago 2023
2022
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Final Analysis from SPEARHEAD-1 Cohort 1 of Afamistresgene Autoleucel (“Afam-cel” [Formerly ADP-A2M4] in Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma.
PDF poster. 2022 CTOS Annual Meeting, November 16-19 2022.
Brian A. Van Tine et all. -
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al. -
Identification of Response Stratification Factors from Pooled Efficacy Analyses of Afamitresgene Autoleucel (“Afami-cel” [Formerly ADP-A2M4]) in Metastatic Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Phase 1 and Phase 2 Trials
PDF poster. American Society of Clinical Oncology (ASCO). June 3-7 2022.
Sandra P. D’Angelo, MD, et al. -
Identifying New Therapeutic Indications for Afamitresgene Autoleucel (“Afami-cel” [Formerly ADP-A2M4]) in Adult and Pediatric Sarcomas Using MAGE-A4 Immunohistochemistry
PDF poster. AACR Special Conference: Sarcomas. May. 9-12, 2022. Montreal, Canada and virtual.
Caddie Laberiano, MD, et al. -
Enrollment of pediatric and adolescent MAGE-A4+ advanced synovial sarcoma patients into Cohort 2 of SPEARHEAD-1: a Phase 2 trial of afamitresgene autoleucel (“afami-cel” [formerly ADP-A2M4])
PDF Poster. AACR Sarcomas. May 9-11 2022.
Sandra P. D’Angelo, MD, et al. -
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al.
2021
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SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF presentation. CTOS Annual Meeting. Nov. 10-13, 2021. Virtual.
Brian van Tine, MD, et al. -
SPEARHEAD-1: Preliminary translational insights from a phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF poster. CTOS Annual Meeting. Nov. 10-13, 2021. Virtual.
Sandra P. D’Angelo, MD, et al. -
Radiation sub-study to characterize safety and tolerability of low-dose radiation in combination with afami-cel in patients with advanced cancers
PDF poster. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual
James Welsh, MD, et al. -
SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
PDF presentation. ASCO Annual Meeting, Jun. 4-8, 2021. Chicago, IL and Virtual.
Sandra D’Angelo, MD, et al. -
Nursing considerations for the use of MAGE-A4-targeted SPEAR T-cells in patients with synovial sarcoma
PDF poster. ONS Conference. Apr. 20, 22, 27, and 29, 2021. Virtual
Erica Elefant, MS, et al.
2020
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Durable responses in patients with synovial sarcoma in the phase 1 trial of ADP-A2M4 (MAGE-A4)
PDF presentation. CTOS Annual Meeting. Nov. 18-21, 2020. Virtual
Brian Van Tine, MD, et al. -
SPEARHEAD-2 trial design: a phase 2 pilot trial of ADP-A2M4 in combination with pembrolizumab in patients with recurrent or metastatic head and neck cancer
PDF poster. ESMO Congress. Sep. 19-21, 2020. Virtual
Ezra Cohen, MD, et al. -
SPEARHEAD-1: A phase 2 trial of ADP-A2M4 SPEAR T-cell in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
PDF Poster. ASCO Annual Meeting. May 29- Jun. 2, 2020. Virtual.
Dejka Araujo, MD, et al. -
Phase 1 dose escalation and expansion trial to assess safety and efficacy of ADP-A2M4 in advanced solid tumors.
PDF Presentation. ASCO Annual Meeting. May 29- Jun. 2, 2020. Virtual.
David Hong, MD, et al.
2019
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ADP-A2M4 (MAGE-A4) in patients with synovial sarcoma
PDF presentation. ESMO congress. Sep. 27-Oct. 1, 2019. Barcelona, Spain.
Brian Van Tine, MD, et al. -
The synovial sarcoma subset analysis of the multi-histology phase I trial of ADP-A2M4 (MAGE-A4)
PDF presentation. CTOS Annual Meeting. Nov. 13-16, 2019. Tokyo, Japan.
Brian Van Tine, MD, et al. -
SPEARHEAD-1 trial design: A phase 2, single-arm, open-label clinical trial of ADP-A2M4 SPEAR T-cells in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD
Dejka Araujo, MD, et al. -
Case reports: Correlates of response following adoptive transfer of ADP-A2M4, affinity-enhanced T-cells targeting MAGE-A4, in synovial sarcoma
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD
Svetlana Fayngerts, PhD, et al.
2018
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Initial safety assessment of MAGE-A4 Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells
PDF poster. ESMO congress. Oct. 19-23, 2018. Munich, Germany.
David Hong, MD, et al. -
Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells targeting MAGE-A4
PDF poster. AACR Annual Meeting. Apr. 14-18, 2018. Chicago, IL.
Joana Senra, PhD, et al.
2017
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Study design: Phase 1 dose escalation, multi-tumor study to assess safety, tolerability and antitumor activity of genetically engineered MAGE-A4 SPEAR T-cells in HLA-A2+ subjects with MAGE-A4+ tumors (NCT03132922)
PDF poster. SITC Annual Meeting. Nov. 8-12, 2017. National Harbor, MD.
David S. Hong, MD, et al.
ADP-A2M4CD8 (MAGE-A4)
2023
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Enhancing Efficacy of TCR-engineered CD4+ T Cells Via Coexpression of CD8α
Journal of Immunotherapy, February 2023, DOI: 10.1097/CJI.0000000000000456.
V. Anderson et al. -
Preliminary Clinical Outcomes of ADP-A2M4CD8, a Next-Generation Autologous T-Cell Receptor T-Cell Therapy, in Patients With Advanced Urothelial Cancer
American Society of Clinical Oncology (ASCO), Genitourinary Cancer Symposium, February 16-18 2023.
Dr David Aggen et al. -
Safety and Efficacy From the Phase 1 SURPASS Trial of ADP-A2M4CD8, a Next-Generation T-Cell Receptor T-Cell Therapy, in Patients With Advanced Esophageal, Esophagogastric Junction, or Gastric Cancer
American Society of Clinical Oncology (ASCO), Gastrointestinal Cancer Symposium Jan 19–21, 2023
Dr Mariela Blum Murphy et al.
2022
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Preliminary Clinical Outcomes of ADP-A2M4CD8, a Next-Generation Autologous T-Cell Receptor T-Cell Therapy, in Patients With Advanced Epithelial Ovarian Cancer,
European Congress on Gynaecological Oncology, October 28-30 2022
Dr Kathleen Moore et al. -
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al. -
SURPASS 2 trial design: A phase 2, open label study of ADP-A2M4CD8 SPEAR T-cells in advanced esophageal or esophagogastric junction cancers
PDF poster. ASCO GI Cancers Symposium. Jan. 20-22, 2022. San Francisco, CA
David S. Hong, MD, et al. - Dr Hong SURPASS Update ESMO 2022
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Real World Treatment Patterns and Outcomes of Metastatic Synovial Sarcoma over the Last Decade in England
PDF poster. European Society for Medical Oncology (ESMO) Congress. September 9-13, 2022. Sandra J. Strauss et al.
2021
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Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion
PDF poster. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual.
Emily Schmidt, PhD, et al. -
Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4
PDF poster. ESMO Congress. Sep. 16-21, 2021. Virtual. David Hong, MD, et al.
2020
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Inhibition of AKT signaling during expansion of TCR-engineered T-cells from patient leukocyte material generates SPEAR T-Cells with enhanced functional potential in vitro
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual.
Katerina Mardilovich, PhD, et al. -
Initial safety, efficacy, and product attributes from the SURPASS Trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual.
David S. Hong, MD, et al.
2019
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SURPASS trial design: A phase 1 dose escalation trial to assess safety and efficacy of ADP-A2M4CD8 in HLA-A2+ patients with MAGE-A4+ tumors
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD.
Paula M. Fracasso, MD, PhD, et al. -
Enhanced activity of second-generation MAGE-A4 SPEAR T-Cells through co-expression of a CD8α homodimer
PDF presentation. AACR Annual Meeting. Mar. 29-Apr. 3, 2019. Atlanta, GA.
Victoria Anderson, PhD, et al.
ADP-A2M10 (MAGE-A10)
2022
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Structural insights into engineering a T-cell receptor targeting MAGE-A10 with higher affinity and specificity for cancer immunotherapy
Journal for ImmunoTherapy of Cancer 2022, 17 July 2022.
Simister PC, et al. -
Manuscript
Phase 1 Clinical Trial Evaluating the Safety and Anti-Tumor Activity of ADP-A2M10 SPEAR T-Cells in Patients With MAGE-A10+ Head and Neck, Melanoma, or Urothelial Tumors. Frontiers in Oncology
Frontiers in Oncology, 18 March 2022.
David S. Hong, MD, et al. -
Manuscript
Phase I clinical trial evaluating the safety and efficacy of ADP-A2M10 SPEAR T cells in patients with MAGE-A10+ advanced non-small cell lung cancer.
Journal for ImmunoTherapy of Cancer 2022 Jan;10(1):e003581.
Blumenschein GR, et al.
2020
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Phase 1 clinical trial evaluating the safety of ADP-A2M10 SPEAR T-cells in patients with MAGE-A10+ advanced non-small cell lung cancer
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual
George R. Blumenschein, MD, et al. -
Phase 1 clinical trial evaluating the safety of ADP-A2M10 SPEAR T-cells in patients with MAGE-A10+ head and neck, melanoma, or urothelial tumors
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual
David S. Hong, MD, et al.
2018
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Manuscript
Affinity-enhanced T-cell receptors for adoptive T-cell therapy targeting MAGE-A10: strategy for selection of an optimal candidate.
OncoImmunology Nov 2018:1-12.
Ellen Border, PhD, et al. -
Safety and anti-tumour effects of MAGE-A10c796TCR T-cells in two clinical trials
PDF poster. ESMO Congress. Oct. 19-23, 2018. Munich, Germany.
Vincent Lam, MD, et al. -
Initial safety assessment of MAGE-A10 Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells in two clinical trials.
PDF poster. ASCO Annual Meeting. Jun.1-5, 2018. Chicago, IL.
Vincent K. Lam, MD, et al. -
Selection of Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells targeting MAGE-A10.
PDF poster. AACR Annual Meeting. Apr. 14-18, 2018. Chicago, IL.
Ellen Border, PhD, et al.
2017
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Two phase I/II open label clinical trials evaluating the safety and efficacy of autologous T cells expressing enhanced TCRs specific for NY-ESO-1 or MAGEA10 in subjects with stage IIIb or stage IV non-small cell lung cancer (NCT02588612/NCT02592577)
PDF poster. ASCO Annual Meeting. Jun. 2-6, 2017. Chicago, IL. Ben Creelan, MD, et al
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A phase I single arm, open label clinical trial evaluating safety of MAGEA10c796T in subjects with advanced or metastatic head and neck, melanoma or urothelial tumors (NCT02989064)
PDF poster. ASCO Annual Meeting. Jun. 2-6, 2017. Chicago, IL.
David Hong, MD, et al.
2015
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Preclinical safety testing of an optimised enhanced-affinity MAGE-A10-specific T cell receptor for adoptive T cell therapy
PDF poster. SITC Annual Meeting. Nov. 4-8, 2015. National Harbor, MD.
Andrew Gerry, PhD, et al.
ADP-A2AFP (AFP)
2022
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Overall Safety and Efficacy From the Phase 1 Trial of ADP-A2AFP SPEAR T-Cells in Patients With Advanced Hepatocellular Carcinoma or Other Cancer Types Expressing Alpha-Fetoprotein.
PDF Poster. ILCA 2022 16th Annual Conference, 1-4 September 2022, Madrid, Spain. Tim Meyer, et al.
2021
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Data from the third dose cohort and expansion phase of a phase 1 trial of ADP-A2AFP SPEAR T-cells for patients with hepatocellular carcinoma and other cancer types expressing alpha-fetoprotein
PDF presentation. ILCA conference. Aug. 30-Sep.2, 2021. Houston, TX and virtual.
Bruno Sangro, MD, et al.
2020
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Data from the third dose cohort of an ongoing study with ADP-A2AFP SPEAR T-cells
PDF presentation. EASL_ILC. Aug. 27–29, 2020. Virtual.
Bruno Sangro, MD, PhD, et al. -
Updated data from cohorts 1 and 2 of an ongoing study with ADP-A2AFP SPEAR T-cells
PDF poster. ESAL_ILC. Aug. 27–29, 2020. Virtual.
Tim Meyer, PhD, et.al.
2019
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Manuscript
Tuning T cell receptor affinity to optimize clinical risk‐benefit when targeting α‐fetoprotein‐positive liver cancer.
Hepatology 2019 December; doi:10.1002/hep.30477.
Docta RY, et al -
Initial safety of AFP SPEAR T-Cells in patients with advanced hepatocellular carcinoma.
PDF poster. AACR Annual Meeting. Mar. 29-Apr. 3, 2019.
Atlanta, GA. Lipika Goyal, MD, et al.
2017
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Study design: Phase I study to evaluate safety and anti-tumor activity of autologous T cells with alpha-feto protein (AFPc332T) receptor in patients with advanced hepatocellular carcinoma (NCT03132792)
PDF poster. AASLD Annual Meeting. Oct. 20-24, 2017. Washington, DC.
Richard S. Finn, MD, et al.
Copyright © 2021 by the American Association for the Study of Liver Diseases. All Rights Reserved
2016
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Targeting alpha fetoprotein with SPEAR (TM) T-cells in hepatocellular carcinoma
PDF poster. ASCO Annual Meeting. Jun. 3-7, 2016. Chicago, IL.
Andrew Gerry, PhD, et al.
HLA Independent TCRs (HiTs)
2021
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In vitro Selection and Engineering of a Human Leukocyte Antigen-Independent T-Cell Receptor (HiT) Recognizing Human Mesothelin
PDF presentation. ASGCT Annual Meeting. May 11-14, 2021. Virtual.
Martyn J. Hiscox, PhD, et al.
Pre-clinical
2022
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A Novel Flow Cytometry Method for Rapid Assessment of Lentiviral Detection
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
Fraser Wilkes, MS, et al. -
Next-Generation, Inducible IL-7–Expressing, Tumor-Infiltrating Lymphocytes by Lentiviral Vector Genetic Modification for Clinical Application
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
Michael Douglas Crowther, PhD, et al. -
IL-7 and CCL19 Expression in Specific Peptide Enhanced Affinity Receptor T-cells Targeting MAGE-A4 Display Improved Survival and Ability to Induce Migration of Immune Cells
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
George R. Pope, PhD, et al.
2021
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Manuscript
Engineering cancer antigen-specific T cells to overcome the immunosuppressive effects of TGF-β.
The Journal of Immunology 2022 Jan 1;208(1):169-180.
Jonathan DS, et al.
PDF upon request.
2020
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Manuscript
Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy
OncoImmunology. 24 Nov 2019. Joseph P. Sanderson et at.
2018
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Development of novel cancer immunotherapy by exploring human immunopeptidome using mass spectrometry
PDF poster. Hupo World Congress. Sep. 30-Oct.3, 2018. Orlando, FL.
Kamila Chughtai, PhD, et al. -
Manuscript
Fludarabine and neurotoxicity in engineered T-cell therapy
Gene Therapy 2018;25:175-191.
Lowe KL, et al.
2017
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Manuscript
Human leucocyte antigen class I-redirected anti-tumour CD4+ T cells require a higher T cell receptor binding affinity for optimal activity than CD8+ T cells.
Clinical & Experimental Immunology 2017;187(1):124-137.
Tan MP, et al.
2013
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Manuscript
Examining the presentation of tumor-associated antigens on peptide-pulsed T2 cells.
Oncoimmunology 2013 September;2(11):e26840.
Bossi G, et al -
Manuscript
Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma.
Blood 2013 August;122(6):863-871.
Linette GP, et al. -
Manuscript
A pharmacologic perspective on newly emerging T-cell manipulation technologies.
British Journal of Clinical Pharmacology 2013 August;76(2):173-187.
Smethurst D.
Allogeneic
2020
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Driving ADP-A2M4 SPEAR Expression from an Endogenous Hematopoietic Lineage Promotor for “Off-the-Shelf” T-Cell Therapy for MAGE-A4+ Solid Tumors
PDF poster. ASGCT Annual Meeting. May 12-May 15, 2020. Virtual.
Garth Hamilton, PhD, et al.
2019
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Differentiating T-Cells from hiPSCs to create off-the-shelf SPEAR T-Cell therapies.
PDF presentation. ASGCT Annual Meeting. Apr. 29-May 2, 2019. Washington DC
Lee Carpenter, PhD, et al.
CMC
2023
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Interview - Ensuring success in working with apheresis centers
Cell & Gene Therapy Insights 2023; 9(2), 141–146 DOI: 10.18609/cgti.2023.019.
Suzanne Kamps
2022
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Building an integrated vector supply to support autologous cell therapy for solid tumours
European Pharmaceutical Review Volume 27, Issue 05, November 2022.
James Nanista and Josh Hunt
2019
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Assessing the potency of SPEAR T cells: development and validation of a flow cytometry-based cytotoxicity assay
PDF poster. BEBPA EUR Bioassay Conference. Sep. 25-27, 2019. Prague, Czechia.
Rachel Kenneil, PhD, et al.
NY-ESO-1
2019
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Manuscript
Long‐term safety and activity of NY-ESO‐1 SPEAR T cells after autologous stem cell transplant for myeloma.
Blood Advances 2019;3:2022-2034.
Stadtmauer EA, et al.
2018
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Manuscript
Antitumor activity associated with prolonged persistence of adoptively transferred NY-ESO-1c259T cells in synovial sarcoma.
Cancer Discovery 2018;8(8):944-957.
D'Angelo SP, et al.
2015
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Manuscript
NY-ESO-1-specific TCR-engineered T cells mediate sustained antigen-specific antitumor effects in myeloma.
Nature Medicine 2015;21(8):914-921.
Rapoport AP, et al.