Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies
Abstract
:1. Introduction
2. Targeting Antigens on Lymphoid Cells
3. Immune Checkpoint Inhibitors
3.1. Targeting CTLA-4
3.2. Targeting PD-1 or PD-L1
4. Chimeric Antigen Receptor (CAR) T-Cells
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
References
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Name | Trade Name | Target | Clinical Study | Clinical Trial Identifier |
---|---|---|---|---|
Monoclonal Antibodies (mAbs) | ||||
Alemtuzumab | Lemtrada | Recombinant humanized rat IgG1κ mAb → CD52 | Phase II study in relapsed ALL, phase II in lymphomas, ALL or AML during AHSCT, phase II study in hematological malignancies before PBSCT and AHSCT | NCT00089349, NCT00061945, NCT00040846, NCT00118352, NCT00027560, NCT02061800 |
Avelumab | Bavencio | Fully human mAb → PD-L1 | Phase II study in pediatric lymphoma | NCT03451825 |
B43 | N/A | Murine mAb conjugated with genistein → CD19 | Phase I study in recurrent ALL or NHL | NCT00004858 |
Basiliximab | Simulect | Chimeric mAb → CD25 | Prevention of organ transplant rejections | NCT02770430, [7] |
Blinatumomab | Blincyto | Recombinant mouse bi-specific T-cell engager (BiTE) → CD19, CD3 | Ph-negative CD19-positive B-ALL r/r or after AHSCT, phase III study in relapsed B-ALL | NCT02101853, NCT02393859, NCT02187354, [8] |
Brentuximab vedotin (or SGN-35) | Adcetris | Recombinant chimeric IgG1 hamster mAb linked to monomethylauristatin E → CD30 → internalization, tubulin polymerization inhibition, M-phase arrest and apoptosis | Phase II study in stage IIB, IIIB or IV, r/r HL, systemic ALCL, phase II study in r/r HL, phase II study in anaplastic large cell lymphoma, phase III study in HL | NCT01920932, NCT01780662, NCT01979536, NCT02166463, NCT02744612 |
Camrelizumab (or SHR-1210) | AiRuiKa | Humanized IgG4κ mAb → PD-1 | Phase II study in r/r HL, phase III study in r/r HL | NCT04026269, NCT04514081, NCT04233294, NCT04510610 |
Daratumumab | Darzalex | Recombinant human IgG1κ mAb → CD38 | Phase II study in r/r leukemia and lymphoma, phase II study in relapsed AML post-AHSCT | NCT03384654, NCT03537599 |
Denintuzumab mafodotin (or SGN-CD19A) | N/A | Humanized mAb conjugated with monomethyl auristatin F → CD19 | Phase I study in r/r B-ALL and lymphomas, phase I study in r/r B-NHL | NCT01786096, NCT01786135 |
DT2219ARL | N/A | Bispecific ligand-directed diphtheria toxin (BiTE) → CD19 and CD22 | Phase I study in r/r CD19+/CD22+ B-ALL and lymphoma | NCT00889408 |
Durvalumab | Imfinzi | Human IgG1κ mAb → checkpoint inhibitor blocking the interaction of PD-L1 with PD-1 | Phase II study in advanced lymphomas | NCT03837899 |
Epratuzumab | LymphoCide | Humanized IgG1 mAb → CD22 | Phase II/III studies in relapsed ALL | NCT00098839, NCT01802814 |
Gemtuzumab ozogamicin | Mylotarg | Humanized mouse IgG4κ mAb linked to N-acetyl gamma calicheamicin → CD33 | Phase II study in APL and recurrent AML, phase III study in AML, phase I study in r/r AML or MDS, phase II study in AML or MDS before PBSCT, phase II study in AML, phase III study in AML | NCT01409161, NCT00070174, NCT00028899, NCT01869803, NCT00372593, NCT00008151, NCT04326439, NCT04293562, [9] |
Ibritumomab tiuxetan | Zevalin | Recombinant murine IgG1 mAb conjugated to the chelating agent MX-DTPA and labelled with 90Y (alternatively with indium 111In) → CD20 | Phase I study in r/r lymphomas | NCT00036855 |
Inolimomab | Leukotac | Murine IgG1 mAb → CD25 | Phase III study in steroid refractory acute GVHD after AHSCT | NCT04289103 |
Inotuzumab ozogamicin | Besponsa | Recombinant humanizedIgG4κ mAb covalently linked to N-acetyl-gamma-calicheamicindimethyl hydrazide → CD22 | Phase II study in MRD+ and r/r CD22+ ALL, phase III study in high-risk B-ALL, mixed phenotype leukemia and B-lymphoma, phase III study in ALL | NCT03913559, NCT03094611, NCT01134575, NCT02981628, NCT03959085, NCT04307576 |
Ipilimumab | Yervoy | Recombinant fully human IgG1κ mAb → CTLA-4 | Phase II study in r/r lymphomas, phase I study in r/r lymphoma, phase I study in MDS after AHSCT | NCT02304458, NCT04500548, NCT01445379, NCT00060372, [10] |
Moxetumomab pasudotox tdfk (or CAT-8015) | Lumoxiti | Immunotoxin consisted of mouse Fv mAb fragment fused to a 38 kDa fragment of Pseudomonas exotoxin A (PE38) → CD22 → internalization → ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death | Phase I study in ALL and NHL, phase II study in B-ALL | NCT00659425, NCT02227108 |
Muromonab-CD3 | Orthoclone OKT3 | Murine IgG2a mAb → CD3 | Phase III study in r/r ALL after AHSCT, phase II study in r/r ALL and lymphoma, APL and MDS before AHSCT | NCT01423747, NCT01423500, NCT00005852 |
Nivolumab | Opdivo | Human IgG4 mAb → PD-1 | Phase I/II study in r/r lymphoma | NCT02304458, NCT04500548 |
Obinutuzumab (or GA101; formerly afutuzumab) | Gazyva, Gazyvaro | Recombinant humanized IgG1 mAb → CD20 | Phase II study in r/r CD20+ NHL | NCT02393157 |
Ofatumumab (or HuMax-CD20 or OMB157) | Arzerra, Kesimpta | Recombinant human IgG1κ mAb → CD20 | Phase II study in recurrent lymphoblastic lymphoma, phase II study in ALL in complete remission | NCT03136146, NCT01363128 |
Ontuxizumab (or MORAb-004) | N/A | Recombinant chimeric humanized IgG1κ mAb → TEM1 | Phase I study in r/r lymphoma | NCT01748721 |
Pembrolizumab (formerly lambrolizumab) | Keytruda | Humanized IgG4κ mAb → PD-1 receptor | Phase I and II studies in r/r lymphoma | NCT03445858, NCT02332668 |
Rituximab | MabThera, Truxima, Rituxan, Reditux, Zytux, Rixathon, Riximyo | Chimeric IgG1κ mAb → CD20 | NHL and CLL, phase II study in B-ALL and lymphoma, phase II study in r/r B-cell lymphoma during PBSCT, phase I study in r/r lymphoma or leukemia or lymphoproliferative disorder related to AHSCT, phase II study in recurrent lymphoblastic lymphoma, phase I study in r/r lymphomas, phase II study in PMBCL, phase II study in r/r B-ALL | NCT00057811, NCT00058461, NCT00867529, NCT00087009, NCT00324779, NCT03136146, NCT00036855, NCT00983944, NCT01700946, [11] |
Tocilizumab | Actemra, RoActemra | Humanized IgG1 mAb → IL6R | Pilot Study in CART19-associated CRS in r/r ALL | NCT02906371 |
Tremelimumab (formerly ticilimumab) | N/A | Fully human IgG2 mAb → CTLA-4 | Phase II study in advanced lymphomas | NCT03837899 |
Fusion Proteins | ||||
Abatacept | Orencia | Extracellular domain of CTLA-4 linked to a modified Fc portion of human IgG1 → inhibits the connection of APCs with CD28 receptor on T-cells by binding CD80 and CD86 → inhibits T-cell activation | Phase II study in GvHD prophylaxis after AHSCT, phase III study in preparative regimen before AHSCT in children with r/r leukemia | NCT01012492, NCT03924401, NCT01743131, NCT04380740, NCT02867800, NCT04000698, [12] |
Chimeric antigen receptor (CAR) T-cells | ||||
BinD19 | N/A | Autologous anti-CD19 CAR TCR-zeta/4-1BB-transduced T lymphocytes | Phase II study in r/r ALL and lymphoma | NCT03265106 |
CAR-T19/CAR-T22 | AUTO3 | Autologous T-cells transduced with CD19/22 CAR-ζ/4-1BB vector | Phase I study in r/r CD19+/CD22+ ALL and lymphoma, phase II study in r/r ALL | NCT04204161, NCT03289455 |
Tisagenlecleucel (or CTL019) | Kymriah | Autologous, immuno-cellular cancer therapy encoding an anti-CD19 CAR | B-ALL and diffuse large B-cell lymphoma, phase II study in r/r B-ALL | NCT02435849, [13] |
Axicabtagene ciloleucel | Yescarta | Autologous T-cells against CD19 → T-cell activation via CD28 and CD3-zeta | Phase II study in r/r pre-B-ALL or r/r B-cell NHL | NCT02625480 |
Reference | Targeted Therapy | Subject | Condition | Concomitant Therapy | Prophylaxis | IFD | Outcome |
---|---|---|---|---|---|---|---|
Schober et al., 2020 [14] | Blinatumomab | 7-year-old-boy | Relapsed ALL after AHSCT | No | Yes | Fulminant Rhizomucor pusillus mucor-mycosis | Deceased |
Kiss et al., 2008 [15] | Rituximab | 15-year-old girl | Refractory ALL | 6-MP + MTX | N/A | Aspergillosis | Deceased |
Kavcic et al., 2013 [16] | Rituximab | 19/479 pediatric patients | Hematologic malignancy | N/A | N/A | 7 with candidiasis, 5 with aspergillosis, and 7 with unspecified mycoses | N/A |
Khandelwal et al., 2014 [17] | Alemtuzumab | 4/19 patients (median age: 4 years old) | Steroid-refractory acute GvHD | Various agents in various combinations (methylprednisolone, cyclosporine A, MTX, sirolimus, tacrolimus, ATG, cyclophosphamide) | Yes | Central nervous system fungal infection, candidemia, corneal fungal infection, respiratory fungal infection | 2/4 deceased |
Shah et al., 2007 [18] | Alemtuzumab | 2/14 patients (3 to 17.8 years old) | GvHD prevention in AHSCT | MTX + tacrolimus | Yes | Candidiasis | Both recovered |
Contreras et al., 2021 [19] | Inotuzumab ozogamicin | 1.8-year old boy | r/r B-ALL with hyper-diploidy | Followed MTX + vincristine/dexamethasone. Blinatumomab “bridging” treatment | N/A | Sinus mucor-mycosis | Recovered |
Yamada et al., 2013 [20] | Gemtuzumab ozogamicin | 2-year-old girl | Relapsed AML (MLL-MLLT10 rearrangement) complicated with HLH | Sorafenib | N/A | Exacerbation of invasive aspergillosis | Deceased |
Liu et al., 2018 [21] | Gemtuzumab ozogamicin | N/A | Refractory CD33+ MDS with monosomy7 & del(5q) | FLAG reinduction | N/A | Invasive aspergillosis | Deceased |
Reinhardt et al., 2004 [22] | Gemtuzumab ozogamicin | 11.8 year-old girl | r/r AML with del(9) | Steroid prophylaxis for infusion-related side effects | N/A | Invasive aspergillosis | Deceased |
Satwani et al., 2012 [23] | Gemtuzumab ozogamicin | 12-year-old boy | MDS with monosomy 7 | Busulfan + cyclophosphamide | Yes | Malassezia furfur sepsis | Survived |
Si et al., 2020 [24] | Pembrolizumab | 18-year-old girl | Refractory PMBCL | No | No | PJP | Survived |
Reference | Target | Cohort | Prophylaxis | IFDs |
---|---|---|---|---|
Ghorashian et al., 2019 [179] | CD19 CAT | 14 pts with ALL | N/A | Early: 2 cases of chest fungal infection (14.3%) |
Vora et al., 2020 [182] | CD19 | 81 pts with ALL, 1 with mixed leukemia and 1 with B-cell lymphoma | Cotrimoxazole or inhaled pentamidine; other antifungal prophylaxis at physician’s discretion (18.1%) | Early: 1 case of invasive pulmonary Cunninghamella infection (1.2%; unknown if pre-existed and exacerbated); Late: none |
Maude et al., 2018 [181] | CD19 | 75 pts with ALL | N/A | Late: 1 fatal systemic mycosis (1.3%) |
Pan et al., 2019 [180] | CD22 | 26 pts with ALL | N/A | Early: Aspergillus pneumonia (probably present prior to enrollment) |
Targeted Therapy | Overall Incidence of IFDs in Adults | IFD Reports in Children |
---|---|---|
Blinatumomab | Very common | Yes |
Basiliximab | Very common | Yes |
Inotuzumab ozogamicin | Very common | Yes |
Gemtuzumab ozogamicin | Very common | Yes |
Alemtuzumab | Very common | Yes |
Tisagenlecleucel | Very common | Yes |
Rituximab | Common | Yes |
Axicabtagene ciloleucel | Common | No |
Durvalumab | Common | No |
Tremelimumab | Common | No |
Abatacept | Uncommon | No |
Ipilimumab | Uncommon | No |
Pembrolizumab | Uncommon | Yes |
Avelumab | Uncommon | No |
Brentuximab vedotin | Uncommon | No |
Moxetumomab pasudotox | Uncommon | No |
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Kyriakidis, I.; Vasileiou, E.; Rossig, C.; Roilides, E.; Groll, A.H.; Tragiannidis, A. Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies. J. Fungi 2021, 7, 186. https://doi.org/10.3390/jof7030186
Kyriakidis I, Vasileiou E, Rossig C, Roilides E, Groll AH, Tragiannidis A. Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies. Journal of Fungi. 2021; 7(3):186. https://doi.org/10.3390/jof7030186
Chicago/Turabian StyleKyriakidis, Ioannis, Eleni Vasileiou, Claudia Rossig, Emmanuel Roilides, Andreas H. Groll, and Athanasios Tragiannidis. 2021. "Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies" Journal of Fungi 7, no. 3: 186. https://doi.org/10.3390/jof7030186