Summary of Study ST003205

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR001998. The data can be accessed directly via it's Project DOI: 10.21228/M8G143 This work is supported by NIH grant, U2C- DK119886.

See: https://www.metabolomicsworkbench.org/about/howtocite.php

This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.

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Study IDST003205
Study TitleMetabolic profile evolution in relapsed/refractory B-NHL patients treated with CD19.CAR-T cell therapy and implications in clinical outcome
Study TypeNMR Metabolomic
Study SummaryPlasma metabolomics analysis was performed on 44 patients with relapsed/refractory B-cell non Hodgkin lymphoma (r/r/B-NHL) infused with approved CD19.CAR-T cell products at the time of pre-lymphodepletion (PLD) and at day +1, +7, and +30 after CAR-T cell infusion. At the PLD time point, a metabolic profile characterized by high lipoproteins and lactate and low glucose contributed to poor outcome prediction in association with high lactate dehydrogenase levels. At day+1, higher plasma levels of lipid metabolism products and lower glucose and glycoproteins levels were observed in tisa-cel- compared to axi-cel-treated patients. At day+30, a higher content of lactate, as well as phenylalanine/tryptophan amino acids which represent the precursors of the key players of myeloid derived suppressor cells were found in patients who relapsed over time compared to patients who maintained complete remission until 1-year. Our data show complex metabolomic changes that track the evolution of the disease and drug activity in the first 30 days of CAR-T cell therapy. Notably, specific metabolic signatures at PLD and day+30, together with a day+30 metabolic profile related to myeloid immunosuppression, are associated with poor outcome.
Institute
UNIVERSITY OF SALENTO
DepartmentD.i.S.T.e.B.A.
LaboratoryGeneral and Inorganic Chemistry
Last NameFANIZZI
First NameFRANCESCO PAOLO
AddressProv.Le Lecce-Monteroni - Centro Ecotekne
Emailfp.fanizzi@unisalento.it
Phone++39-0832-299265
Submit Date2024-05-02
Raw Data AvailableYes
Raw Data File Type(s)fid
Analysis Type DetailNMR
Release Date2024-06-07
Release Version1
FRANCESCO PAOLO FANIZZI FRANCESCO PAOLO FANIZZI
https://dx.doi.org/10.21228/M8G143
ftp://www.metabolomicsworkbench.org/Studies/ application/zip

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Project:

Project ID:PR001998
Project DOI:doi: 10.21228/M8G143
Project Title:CAR-T therapy metabolomic study
Project Summary:Plasma metabolomics analysis was performed on 44 patients with relapsed/refractory B-cell non Hodgkin lymphoma (r/r/B-NHL) infused with approved CD19.CAR-T cell products at the time of pre-lymphodepletion (PLD) and at day +1, +7, and +30 after CAR-T cell infusion. At the PLD time point, a metabolic profile characterized by high lipoproteins and lactate and low glucose contributed to poor outcome prediction in association with high lactate dehydrogenase levels. At day+1, higher plasma levels of lipid metabolism products and lower glucose and glycoproteins levels were observed in tisa-cel- compared to axi-cel-treated patients. At day+30, a higher content of lactate, as well as phenylalanine/tryptophan amino acids which represent the precursors of the key players of myeloid derived suppressor cells were found in patients who relapsed over time compared to patients who maintained complete remission until 1-year. Our data show complex metabolomic changes that track the evolution of the disease and drug activity in the first 30 days of CAR-T cell therapy. Notably, specific metabolic signatures at PLD and day+30, together with a day+30 metabolic profile related to myeloid immunosuppression, are associated with poor outcome.
Institute:UNIVERSITY OF SALENTO
Department:D.i.S.T.e.B.A.
Laboratory:General and Inorganic Chemistry
Last Name:FANIZZI
First Name:FRANCESCO PAOLO
Address:Prov.Le Lecce-Monteroni - Centro Ecotekne, LECCE, LECCE, 73100, Italy
Email:fp.fanizzi@unisalento.it
Phone:++39-0832-299265

Subject:

Subject ID:SU003324
Subject Type:Human
Subject Species:Homo sapiens
Taxonomy ID:9606

Factors:

Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id local_sample_id Time point Sample source Therapy
SA348808CAR-65 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348809CAR-46_+1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348810CAR-75 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348811CAR-69 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348812CAR-33_+1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348813CAR-61 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348814CAR-45_+1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348815CAR-76 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348816CAR-59 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348817CAR-92 +1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348818CAR-51_+1DAfter 1 Day post-infusion (1D) plasma axi-cell
SA348819CAR-55 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348820CAR-57 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348821CAR-40_+1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348822CAR-38_+1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348823CAR-58 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348824CAR-44_+1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348825CAR-71 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348826CAR-53 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348827CAR-47_+1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348828CAR-66 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348829CAR-43_+1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348830CAR-72 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348831CAR-77 +1DAfter 1 Day post-infusion (1D) plasma tisa-cell
SA348832CAR-53 +30DAfter 30 Days post-infusion (30D) (30D) plasma tisa-cell
SA348833CAR-65 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348834CAR-45_+30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348835CAR-75 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348836CAR-92 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348837CAR-46_+30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348838CAR-33_+30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348839CAR-69 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348840CAR-51_+30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348841CAR-76 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348842CAR-59 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348843CAR-61 +30DAfter 30 Days post-infusion (30D) plasma axi-cell
SA348844CAR-47_+30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348845CAR-77 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348846CAR-44_+30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348847CAR-72 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348848CAR-58 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348849CAR-71 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348850CAR-57 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348851CAR-38_+30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348852CAR-66 +30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348853CAR-43_+30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348854CAR-40_+30DAfter 30 Days post-infusion (30D) plasma tisa-cell
SA348855CAR-59 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348856CAR-92 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348857CAR-51_+7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348858CAR-75 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348859CAR-69 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348860CAR-65 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348861CAR-76 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348862CAR-45_+7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348863CAR-61 +7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348864CAR-46_+7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348865CAR-33_+7DAfter 7 Days post-infusion (7D) plasma axi-cell
SA348866CAR-66 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348867CAR-71 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348868CAR-72 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348869CAR-77 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348870CAR-58 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348871CAR-53 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348872CAR-47_+7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348873CAR-43_+7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348874CAR-38_+7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348875CAR-40_+7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348876CAR-57 +7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348877CAR-44_+7DAfter 7 Days post-infusion (7D) plasma tisa-cell
SA348878CAR-19-APre-lymphodepletion plasma axi-cell
SA348879CAR-28-APre-lymphodepletion plasma axi-cell
SA348880CAR-69 INGPre-lymphodepletion plasma axi-cell
SA348881CAR-32-APre-lymphodepletion plasma axi-cell
SA348882CAR-16-APre-lymphodepletion plasma axi-cell
SA348883CAR-21-APre-lymphodepletion plasma axi-cell
SA348884CAR-13-APre-lymphodepletion plasma axi-cell
SA348885CAR-5-APre-lymphodepletion plasma axi-cell
SA348886CAR-3-APre-lymphodepletion plasma axi-cell
SA348887CAR-92 INGPre-lymphodepletion plasma axi-cell
SA348888CAR-83 INGPre-lymphodepletion plasma axi-cell
SA348889CAR-7-APre-lymphodepletion plasma axi-cell
SA348890CAR-75 INGPre-lymphodepletion plasma axi-cell
SA348891CAR-12-APre-lymphodepletion plasma axi-cell
SA348892CAR-76 INGPre-lymphodepletion plasma axi-cell
SA348893CAR-15-APre-lymphodepletion plasma axi-cell
SA348894CAR-33-APre-lymphodepletion plasma axi-cell
SA348895CAR61-INGPre-lymphodepletion plasma axi-cell
SA34889645-EPre-lymphodepletion plasma axi-cell
SA348897CAR59-INGPre-lymphodepletion plasma axi-cell
SA34889851-EPre-lymphodepletion plasma axi-cell
SA348899CAR-1-APre-lymphodepletion plasma axi-cell
SA348900CAR65-INGPre-lymphodepletion plasma axi-cell
SA34890146-EPre-lymphodepletion plasma axi-cell
SA348902CAR57-INGPre-lymphodepletion plasma tisa-cell
SA348903CAR-77 INGPre-lymphodepletion plasma tisa-cell
SA348904CAR66-INGPre-lymphodepletion plasma tisa-cell
SA348905CAR-9-APre-lymphodepletion plasma tisa-cell
SA348906CAR53-INGPre-lymphodepletion plasma tisa-cell
SA348907CAR-4-APre-lymphodepletion plasma tisa-cell
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Collection:

Collection ID:CO003317
Collection Summary:Blood samples were collected at the PLD time point and day +1 (D1), +7 (D7), and +30 (D30) after CAR-T cell infusion, when available. Plasma separation was performed by centrifugation at 1000xg for 15 minutes at room temperature. Plasma aliquots were collected and stored at -80°C.
Sample Type:Blood (plasma)
Storage Conditions:-80℃

Treatment:

Treatment ID:TR003333
Treatment Summary:This is a prospective observational tissue study performed in patients affected by r/r B-NHL after CD19.CAR-T cell therapy with axi-cel and tisa-cel. Only patients with diffuse large B‐cell lymphoma (DLBCL), DLBCL transformed from follicular lymphoma (tFL), high-grade B-cell lymphoma (HGBCL), and primary mediastinal B‐cell lymphoma (PMBCL) were included. Cytokine release syndrome (CRS) and immune effector cell‐associated neurotoxicity syndrome (ICANS) were graded according to the American Society for Transplantation and Cellular Therapy (ASCT) criteria. All eligible patients were treated at IRCCS AOU di Bologna, after signing a written informed consent. The study was approved by the local Ethical Committee in agreement with the Helsinki Declaration and registered at clinicaltrial.gov NCT04892433. 44 patients with relapsed/refractory B-cell non Hodgkin lymphoma (r/r/B-NHL) were infused with approved CD19.CAR-T cell products at the time of pre-lymphodepletion (PLD) and at day 1, 7, and 30 after CAR-T cell infusion. Other parameters as TRIGLYCERIDES (mg/dL); Lactate dehydrogenase (LDH) (U/L); FERRITIN (ng/mL); PROTEIN C REACTIVE (PCR) (mg/dL) are available for each patient. The follow up of patients are indicated as Complete Remission (CR); Partial Disease (PD) and Partial Response (PR).

Sample Preparation:

Sampleprep ID:SP003331
Sampleprep Summary:Plasma samples were thawed at room temperature and 5 mm NMR tubes were prepared for NMR measurement by adding 200 µL of sample with 400 µL of saline buffer solution at pH 7.4 (NaCl 0.9%, 50 mM of sodium phosphate buffer in D2O containing trimethylsilyl propionic-2,2,3,3-d4 acid sodium salt, TSP).

Analysis:

Analysis ID:AN005257
Analysis Type:NMR
Analysis Protocol File:NMR_analysis_protocol_file.pdf
Results File:ST003205_AN005257_Results.txt
Units:ppm

NMR:

NMR ID:NM000282
Analysis ID:AN005257
Instrument Name:Bruker Avance III NMR
Instrument Type:FT-NMR
NMR Experiment Type:1D-1H
Spectrometer Frequency:600.13 MHz
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