^
24d
REGAL: galinpepimut-S vs. best available therapy as maintenance therapy for acute myeloid leukemia in second remission. (PubMed, Future Oncol)
Clinical trial registration: https://clinicaltrials.gov/study/NCT04229979. The clinical trial identifier is NCT04229979.
Clinical • Journal
|
WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
1m
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy
|
temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
1m
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
1m
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
P1/2, N=26, Completed, Sellas Life Sciences Group | Active, not recruiting --> Completed | N=90 --> 26
Trial completion • Enrollment change • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
HER-2 negative • KRAS wild-type • RAS wild-type • BRCA mutation • PGR negative
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
1m
Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024
Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
2ms
INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
P1, N=44, Recruiting, University of Pennsylvania | Phase classification: P1b --> P1
Phase classification
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
BRCA2 mutation • BRCA1 mutation
|
INO-5401 • rocakinogene sifuplasmid (INO-9012)
2ms
Enrollment change
|
WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
3ms
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation (clinicaltrials.gov)
P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2
Trial completion • Phase classification
|
WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule)
|
WT1 expression • WT1 positive
|
lenalidomide • bortezomib • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
4ms
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Active, not recruiting, 3D Medicines | Trial primary completion date: May 2024 --> Dec 2024
Trial primary completion date
|
WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
4ms
New P1 trial • Metastases
5ms
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
5ms
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov)
P1/2, N=24, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • WT1 (WT1 Transcription Factor)
|
Keytruda (pembrolizumab) • ASP7517
7ms
Enrollment change
7ms
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
8ms
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
8ms
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=47, Terminated, Sumitomo Pharma America, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Sponsor's decision to terminate development of the program.
Phase classification • Trial termination • Combination therapy • Checkpoint inhibition • Metastases
|
MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
MSI-H/dMMR • HLA-A*02 • HLA-A*24
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
9ms
SLSG18-301: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting
Enrollment closed
|
Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
10ms
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov)
P1/2, N=24, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2027 --> Jun 2024 | Trial primary completion date: Dec 2027 --> Jun 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • WT1 (WT1 Transcription Factor)
|
EGFR mutation • ALK positive • ALK mutation
|
Keytruda (pembrolizumab) • ASP7517
11ms
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
12ms
Dose Escalation Trial of WT1-specific Donor-derived T Cells Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1)
|
melphalan • fludarabine IV • busulfan • ATA520
1year
WP42004: A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420. (clinicaltrials.gov)
P1, N=59, Completed, Hoffmann-La Roche | Recruiting --> Completed | N=220 --> 59 | Trial completion date: Feb 2026 --> Aug 2023 | Trial primary completion date: Feb 2026 --> Aug 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02
|
dasatinib • Actemra IV (tocilizumab) • RG6007 • dexamethasone injection
1year
Dose Escalation of HLA-A2-WT1 CD3 T-Cell Bispecific Antibody in a Phase I Study in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) (ASH 2023)
RO7283420 is the first TCR-L TCB antibody evaluated in AML. We observed pharmacodynamic evidence of T-cell activation and expansion in the clinic, in line with the expected MoA of TCBs, however, at the explored doses, no clear exposure-response relationship and only a modest clinical activity were observed. The safety profile was shown to be consistent with the other TCBs and R/R AML population.
Clinical • P1 data
|
TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • WT1 (WT1 Transcription Factor)
|
HLA-A*02
|
RG6007
1year
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Active, not recruiting, 3D Medicines | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> May 2024
Enrollment closed • Trial primary completion date
|
WT1 (WT1 Transcription Factor)
|
WT1 expression • WT1 positive
|
Zeltherva (galinpepimut-S)
1year
PHASE 1/2 STUDY OF GALINPEPIMUT-S PLUS PEMBROLIZUMAB COMBINATION IN PATIENTS WITH WT1+ PLATINUM-RESISTANT OVARIAN CANCER IN 2ND/3RD LINE OF THERAPY (IGCS 2023)
Safety: N=25, GPS alone=8 (due to disease progression); >1 dose of combination =17. Median age: 64-yrs; median number of prior lines: 2. Five patients experienced 11 SAEs, one of which was drug related.
Clinical • P1/2 data
|
CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S)
over1year
WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. (PubMed, Leukemia)
Oral azacytidine may be used as maintenance treatment in AML in first remission, but can be associated with substantial side effects, and less toxic strategies should be explored. OS at five years was 75% (95% CI: 50-89), with 70% of patients ≥60 years of age being long-term survivors. Maintenance therapy with this DC vaccine was well tolerated in AML patients in CR1 and was accompanied by encouraging 5-year long-term survival.
Journal
|
PRAME (Preferentially Expressed Antigen In Melanoma)
|
azacitidine • CVT-DC-01 • DC vaccine for prostate cancer
over1year
Enrollment open
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02
|
dasatinib • Actemra IV (tocilizumab) • RG6007 • dexamethasone injection
over1year
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
over1year
Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT (clinicaltrials.gov)
P1, N=11, Terminated, Mana Therapeutics | N=27 --> 11 | Active, not recruiting --> Terminated; Product manufacturing
Enrollment change • Trial termination
|
MANA-312
over1year
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P1/2, N=43, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Jun 2023 | Trial primary completion date: Feb 2024 --> Jun 2023
Trial completion • Trial completion date • Trial primary completion date
|
ASP7517
over1year
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
over1year
Trial suspension
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02
|
dasatinib • Actemra IV (tocilizumab) • RG6007 • dexamethasone injection
almost2years
The Essential Glucose Transporter GLUT1 is Epigenetically Upregulated by C/EBPb and WT1 During Decidualization of Human Endometrial Stromal Cells. (SRI 2023)
Glucose uptake was examined by 2-deoxyglucose uptake assay... GLUT1 is involved in the increase of glucose uptake in ESCs during decidualization. The up-regulation of GLUT1 is mediated by the promoter bindings of C/EBPβ and WT1. Furthermore, both C/EBPβ and WT1 contribute to induce the epigenetic changes of the GLUT1 promoter by recruiting p300.
Stroma
|
WT1 (WT1 Transcription Factor) • IGFBP1 (Insulin Like Growth Factor Binding Protein 1) • SLC2A1 (Solute Carrier Family 2 Member 1)
almost2years
Targeting leukemic stem cell subpopulation in AML using phytochemicals: An in-silico and in-vitro approach. (PubMed, Comput Biol Med)
The results revealed Gallic acid (GA) and Chlorogenic acid (CA) as promising WT1 inhibitors...We found that GA significantly downregulated both these genes compared to CA. Our results suggested that GA is a potential inhibitor of WT1 and might be an excellent anti-LSCs natural drug for AML patients.
Preclinical • Journal • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2) • WT1 (WT1 Transcription Factor)
|
BCL2 expression
|
chlorogenic acid
almost2years
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov)
P1/2, N=24, Active, not recruiting, Astellas Pharma Global Development, Inc. | N=385 --> 24
Enrollment change • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • WT1 (WT1 Transcription Factor)
|
EGFR mutation • ALK positive • ALK mutation
|
Keytruda (pembrolizumab) • ASP7517
almost2years
Phase I Study of a Multivalent WT1 Peptide Vaccine (Galinpepimut-S) in Combination with Nivolumab in Patients with WT1-Expressing Ovarian Cancer in Second or Third Remission. (PubMed, Cancers (Basel))
Therapy included six (every two weeks) subcutaneous inoculations of galinpepimut-S vaccine adjuvanted with Montanide, low-dose subcutaneous sargramostim at the injection site, with intravenous nivolumab over 12 weeks, and up to six additional doses until disease progression or toxicity. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses, as indicated by immunophenotyping and WT1-specific IgG production. Exploratory analysis for efficacy yielded a promising 1-year PFS rate.
P1 data • Journal • Combination therapy
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
almost2years
Trial completion • Combination therapy
|
MGMT (6-O-methylguanine-DNA methyltransferase) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02 • HLA-A*24:02
|
Avastin (bevacizumab) • adegramotide/nelatimotide (DSP-7888)
almost2years
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov)
P1/2, N=385, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • WT1 (WT1 Transcription Factor)
|
EGFR mutation • ALK positive • ALK mutation
|
Keytruda (pembrolizumab) • ASP7517
almost2years
Dose Escalation Trial of WT1-specific Donor-derived T Cells Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
Trial completion date • Trial primary completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1)
|
melphalan • fludarabine IV • busulfan • ATA520
2years
Shikonin as a WT1 Inhibitor Promotes Promyeloid Leukemia Cell Differentiation. (PubMed, Molecules)
shikonin can down-regulate the WT1 protein level for leukemia differentiation therapy, and 2. the interaction between WT1 and CD34 proteins may be responsible for granulocyte/monocyte immaturity in HL-60 cells.
Journal
|
WT1 (WT1 Transcription Factor) • CD34 (CD34 molecule) • ITGAM (Integrin, alpha M)
|
WT1 overexpression
2years
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1b/2, N=47, Completed, Sumitomo Pharma Oncology, Inc. | Active, not recruiting --> Completed | N=84 --> 47
Trial completion • Enrollment change • Combination therapy • Checkpoint inhibition • Metastases
|
MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
MSI-H/dMMR • HLA-A*02
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
2years
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
2years
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1b/2, N=84, Active, not recruiting, Sumitomo Pharma Oncology, Inc. | Trial completion date: Feb 2024 --> Nov 2022 | Trial primary completion date: Aug 2023 --> Oct 2022
Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
|
MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
MSI-H/dMMR • HLA-A*02
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)