^
    5d
    KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=462, Recruiting, Asher Biotherapeutics, Inc. | N=262 --> 462 | Trial completion date: Oct 2025 --> May 2027 | Trial primary completion date: Jun 2025 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • AB248
    24d
    ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
    P2, N=3, Terminated, Adaptimmune | N=45 --> 3 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Apr 2023; Study was terminated due to difficulty recruiting subjects and lack of efficacy
    Enrollment change • Trial termination • Trial primary completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02 • HLA-A2 positive • MAGEA4 expression
    |
    uzatresgene autoleucel (ADP-A2M4CD8)
    2ms
    IL-2 targeted to CD8+ T cells promotes robust effector T cell responses and potent antitumor immunity. (PubMed, Cancer Discov)
    Efficacy was associated with expansion and phenotypic enhancement of tumor-infiltrating CD8+ T cells, including the emergence of a "better effector" population. These data support the potential utility of AB248 in clinical settings.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    AB248
    2ms
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001） (clinicaltrials.gov)
    P1, N=66, Recruiting, L & L biopharma Co., Ltd., Shanghai China | Trial primary completion date: Sep 2026 --> Sep 2025
    Trial primary completion date • Metastases
    |
    Bis2
    3ms
    ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) (clinicaltrials.gov)
    P1, N=120, Recruiting, Adaptimmune | Trial primary completion date: Sep 2023 --> Dec 2025
    Trial primary completion date • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02 • MAGEA4 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    4ms
    Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    NEXI-002
    4ms
    Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT (clinicaltrials.gov)
    P1/2, N=22, Active, not recruiting, NexImmune Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    cyclophosphamide • NEXI-001
    4ms
    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, NexImmune Inc. | Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Jul 2024 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    cyclophosphamide • fludarabine IV • NEXI-003
    5ms
    KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=262, Recruiting, Asher Biotherapeutics, Inc.
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • AB248
    5ms
    Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers (clinicaltrials.gov)
    P1, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • rhIL-15
    6ms
    KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=262, Recruiting, Asher Biotherapeutics, Inc. | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • AB248
    7ms
    Phase 1 trial of 4-1BB-based adoptive T-cell therapy targeting human telomerase reverse transcriptase in patients with advanced refractory solid tumors. (PubMed, Cytotherapy)
    The generation of TERTiNTs was feasible and safe and provided an interesting disease control rate in heavily pre-treated cancer patients.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    CD8 (cluster of differentiation 8) • TERT (Telomerase Reverse Transcriptase)
    |
    cyclophosphamide • fludarabine IV • EU204 • EU211
    7ms
    A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY AND TREATMENT REGIMENS OF VTP-300 COMBINED WITH LOW-DOSE NIVOLUMAB IN CHRONIC HEPATITIS B INFECTION (AASLD 2023)
    VTP-300 is a novel antigen-specific investigational immunotherapy which has shown (in a Phase 1b/2a study) meaningful and durable HBsAg reductions in patients with HBV as a monotherapy and in combination with LDN. Evaluating the addition and timing of PD-1 inhibitor administration and a second boost of MVA-HBV is critical to optimizing the regimen of VTP-300 which may be a critical component of a functional cure regimen.
    Clinical • P2b data
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    Opdivo (nivolumab)
    10ms
    Clinical and translational data from the phase I SURPASS trial of ADP-A2M4CD8 T cell receptor (TCR) T cell therapy alone or combined with nivolumab in solid tumors (ESMO 2023)
    Nevertheless, inhibition of immunosuppressive pathways may improve anti-tumor responses; therefore, new SURPASS cohorts include ADP-A2M4CD8 combined with nivolumab or pembrolizumab. Data from additional pts treated by August 2023 will be presented. Conclusions ADP-A2M4CD8 continues to show an acceptable benefit-to-risk profile, including in pts receiving nivolumab combination therapy.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    MAGEA4 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    10ms
    A Phase 2 Study (GOG-3084) Of ADP-A2M4CD8 TCR T-Cell Therapy, Alone Or In Combination With Nivolumab, In Patients With Recurrent Ovarian Cancers (ESGO 2023)
    Lymphodepletion chemotherapy (fludarabine 30 mg/m2/day for 4 days and cyclophosphamide 600 mg/m2/day for 3 days) will be followed by infusion of 1â10x10^9 ADP-A2M4CD8 T-cells. Adverse events will be monitored, with participants followed for 15 years from T-cell infusion. Conclusion SURPASS-3 is initiating in Q2 2023.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule) • MAGEA4 (Melanoma antigen family A, 4)
    |
    CD8 expression • HLA-A*02 • HLA-A*02:01 + MAGEA4 expression • MAGEA4 expression
    |
    Opdivo (nivolumab) • cyclophosphamide • fludarabine IV • uzatresgene autoleucel (ADP-A2M4CD8)
    11ms
    ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) (clinicaltrials.gov)
    P2, N=66, Recruiting, Adaptimmune | Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023
    Enrollment open • Trial initiation date • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02:01 • HLA-A*02 • BRCA mutation • HLA-A2 positive • MAGEA4 expression
    |
    Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    11ms
    ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Adaptimmune | Trial primary completion date: Apr 2023 --> Dec 2023
    Trial primary completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02 • HLA-A2 positive • MAGEA4 expression
    |
    uzatresgene autoleucel (ADP-A2M4CD8)
    1year
    A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of LB4330, a peptide fused to CLDN18.2 antibody targeting the tumor antigen associated CD8+t CELLS in patients with advanced solid tumors. (ASCO 2023)
    Enrollment in cohort 1 began in Nov 2022. Clinical trial information: NCT05707676.
    Clinical • P1 data • PK/PD data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8)
    |
    Bis2
    1year
    An analysis of a first-in-human study of NEXI-001 donor-derived antigen-specific CD8+ T-cell treatment of relapsed AML after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2023)
    Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity.
    P1 data
    |
    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
    |
    NEXI-001
    1year
    Modulation of Single-Cell Gene Expression and Cell Function in Evolving Manufacturing Processes for Clinical Trials with Enhanced-Affinity T-Cell Receptor T-Cell Therapy Targeting the MAGE-A4 Antigen in Solid Tumors (ASGCT 2023)
    Introduction: Affinity-enhanced T-cell receptor (TCR) T-cell therapies targeting the intracellular cancer testis antigen MAGE-A4 have shown encouraging results in adults with advanced solid cancers.1,2 Here we explore how TCR T-cell therapy manufacturing process evolution may modulate the function of ADP-A2M4CD8, the next generation counterpart of afamitresgene autoleucel (afami-cel; formerly ADP-A2M4), using single-cell RNA sequencing (scRNA-seq) and in vitro functional assessment. Whole-transcriptome, single-cell investigation of the cellular subsets produced during manufacturing of afami-cel and ADP-A2M4CD8 indicate that infusion of cells with a less cytotoxic GEP does not prevent broad anti-tumor efficacy and may correspond with beneficial characteristics. 1. Van Tine BA, et al.
    Clinical • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • MAGEA4 (Melanoma antigen family A, 4)
    |
    afamitresgene autoleucel (ADP-A2M4) • uzatresgene autoleucel (ADP-A2M4CD8)
    1year
    ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Adaptimmune | Recruiting --> Active, not recruiting | Trial completion date: Oct 2038 --> Dec 2023
    Enrollment closed • Trial completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02 • HLA-A2 positive • MAGEA4 expression
    |
    uzatresgene autoleucel (ADP-A2M4CD8)
    1year
    An open-label, phase 1a/b study of AB248, a CD8+ selective IL-2 mutein fusion protein, alone or in combination with pembrolizumab in patients with advanced solid tumors (AACR 2023)
    Adverse events will be assessed by CTCAE v5.0. The study is currently open for enrollment in the dose escalation phase at multiple sites in the US.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • AB248
    1year
    Increasing the Awareness of Nurses on Evolving Cell Therapies (ONS 2023)
    Purpose: This abstract presents data on two cell therapies being tested in clinical trials, afamitresgene autoleucel (afami-cel; formerly ADP-A2M4) and its next-generation counterpart ADP-A2M4CD8, to inform nurses on new promising therapies...SURPASS (NCT04044859) is a Phase 1, first-in-human trial evaluating ADP-A2M4CD8 as monotherapy or in combination with nivolumab in multiple tumor types... Nurses play key roles at every stage in the administration of T-cell therapy. Understanding advances in cancer treatment and associated clinical data will better prepare nurses to effectively manage patients that may benefit from these novel therapies.
    Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule)
    |
    HLA-A*02
    |
    Opdivo (nivolumab) • afamitresgene autoleucel (ADP-A2M4) • uzatresgene autoleucel (ADP-A2M4CD8)
    over1year
    ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) (clinicaltrials.gov)
    P1, N=120, Recruiting, Adaptimmune | N=90 --> 120
    Enrollment change • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02 • MAGEA4 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    over1year
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001） (clinicaltrials.gov)
    P1, N=66, Recruiting, L & L biopharma Co., Ltd., Shanghai China
    New P1 trial • Metastases
    |
    CLDN18 (Claudin 18)
    |
    Bis2
    over1year
    Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6 (clinicaltrials.gov)
    P2, N=176, Recruiting, Alkermes, Inc. | N=110 --> 176
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    nemvaleukin alfa (ALKS 4230)
    over1year
    A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=262, Recruiting, Asher Biotherapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Keytruda (pembrolizumab) • AB248
    over1year
    Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome (clinicaltrials.gov)
    P1, N=6, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> May 2022
    Trial completion • Trial completion date
    |
    TNFRSF8 (TNF Receptor Superfamily Member 8) • IL15 (Interleukin 15)
    |
    Poteligeo (mogamulizumab-kpkc) • rhIL-15
    over1year
    A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=170, Recruiting, HiFiBiO Therapeutics | Phase classification: P1 --> P1a/1b | N=90 --> 170 | Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    Tevimbra (tislelizumab) • HFB200301
    over1year
    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, NexImmune Inc. | Initiation date: Dec 2022 --> Mar 2023
    Trial initiation date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule)
    |
    cyclophosphamide • fludarabine IV • NEXI-003
    over1year
    A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=262, Not yet recruiting, Asher Biotherapeutics, Inc.
    New P1 trial • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Keytruda (pembrolizumab) • AB248
    over1year
    Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Nov 2022 --> Dec 2023 | Terminated --> Suspended | Trial primary completion date: Aug 2022 --> Nov 2023
    Trial completion date • Trial suspension • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    NEXI-002
    over1year
    Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers (clinicaltrials.gov)
    P1, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • rhIL-15
    over1year
    Nemvaleukin alfa, a novel engineered IL-2 fusion protein, drives antitumor immunity and inhibits tumor growth in small cell lung cancer. (PubMed, J Immunother Cancer)
    mNemvaleukin, a novel cytokine-based immunotherapy, significantly inhibited murine SCLC tumor growth and prolonged survival, which was further enhanced by the addition of chemotherapy. mNemvaleukin alone, and in combination with chemotherapy, drove a strong antitumor immune program elicited by cytotoxic immune cells. Our findings support the evaluation of nemvaleukin alone or in combination with chemotherapy in clinical trials for the treatment of SCLC.
    Journal • IO biomarker
    |
    RB1 (RB Transcriptional Corepressor 1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • RBL2 (RB Transcriptional Corepressor Like 2)
    |
    cisplatin • etoposide IV • nemvaleukin alfa (ALKS 4230)
    over1year
    Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=9, Terminated, NexImmune Inc. | N=22 --> 9 | Recruiting --> Terminated; Lack of accrual
    Enrollment change • Trial termination
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    NEXI-002
    over1year
    Initial Characterization of Nexi-001, a Donor-Derived T-Cell Product, for the Treatment AML Patients That Have Relapsed after Allogeneic Hematopoietic Stem Cell Transplant (ASH 2022)
    In summary, we have developed a novel AIM np-based T cell expansion platform for the rapid, streamlined generation of clinically relevant number of tumor-specific, multi-antigen, memory CD8+ T cells in 14 days. The results reported here support the development of additional multi-institution phase 1 /2 clinical trials of adoptive T cell transfer in hematologic and solid cancers.
    Clinical
    |
    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
    |
    NEXI-001
    over1year
    ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Adaptimmune
    New P2 trial • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02:01 • HLA-A*02 • BRCA mutation • HLA-A2 positive • MAGEA4 expression
    |
    Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    over1year
    First-in-human study to evaluate the safety and clinical activity of FS222, a tetravalent bispecific antibody targeting PD-L1 and CD137, in patients with advanced solid tumors (ESMO-IO 2022)
    The CR remained persistent 10 months later. Conclusions Thus far, FS222 has demonstrated manageable tolerability and early signs of antitumor activity.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    PD-L1 underexpression • PD-L1-L
    |
    FS222
    over1year
    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, NexImmune Inc.
    New P1 trial
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule)
    |
    cyclophosphamide • fludarabine IV • NEXI-003
    over1year
    AB821 is a CD8+ T cell selective IL-21 with enhanced bioavailability that mediates potent anti-tumor activity, cytotoxicity, and expansion of memory CD8+ T cells (SITC 2022)
    AB821 promotes cytotoxicity and memory CD8+ T cells in the context of antigen activation and synergizes with PD1 blockade in PD1-resistant tumors. Clinical development of AB821 is planned.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • STAT3 (Signal Transducer And Activator Of Transcription 3) • CD4 (CD4 Molecule) • GZMB (Granzyme B) • IL21 (Interleukin 21)
    |
    AB821
    over1year
    Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies (clinicaltrials.gov)
    P1, N=8, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> May 2022
    Trial completion • Trial completion date • Combination therapy
    |
    TNFRSF8 (TNF Receptor Superfamily Member 8) • IL15 (Interleukin 15) • IL5 (Interleukin 5)
    |
    PD-L1 expression
    |
    Bavencio (avelumab) • rhIL-15
    over1year
    ARTISTRY-7: PHASE 3 MULTICENTER STUDY OF NEMVALEUKIN ALFA PLUS PEMBROLIZUMAB VERSUS CHEMOTHERAPY IN PATIENTS WITH PLATINUM-RESISTANT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER (IGCS 2022)
    Patients must have had ≥1 prior line of systemic therapy (platinum-sensitive setting), ≤5 prior lines (platinum-resistant setting), and prior bevacizumab, with radiographic progression on most recent therapy. Trial in progress: there are no available conclusions at the time of submission
    Clinical • P3 data
    |
    CD8 (cluster of differentiation 8)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • nemvaleukin alfa (ALKS 4230)