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15d
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 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
1m
TACTOPS: TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=37, Completed, Baylor College of Medicine | Trial completion date: May 2027 --> Jul 2025 | Active, not recruiting --> Completed
Trial completion • Trial completion date
2ms
REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
P3, N=127, Active, not recruiting, Sellas Life Sciences Group | Trial primary completion date: Sep 2025 --> Dec 2025
Trial primary completion date
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Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
4ms
Dose escalation study of the HLA-A2-WT1 CD3 bispecific antibody RO7283420 in relapsed/refractory acute myeloid leukemia. (PubMed, Blood Neoplasia)
Although dose escalation was discontinued because of limited efficacy and lack of an exposure-BM response relationship, the observed pharmacodynamics underscore the promising potential of this class of TCBs targeting intracellular antigens. This trial was registered at www.clinicaltrials.gov as #NCT04580121.
Clinical • Journal
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CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor)
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RG6007
5ms
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
P1/2, N=35, Completed, Inovio Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Dec 2025 --> May 2025
Trial completion • Trial completion date • Trial primary completion date
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Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
6ms
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Active, not recruiting, 3D Medicines | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
Trial completion date • Trial primary completion date
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WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
7ms
REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
P3, N=128, Active, not recruiting, Sellas Life Sciences Group | Trial completion date: Mar 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Sep 2025
Trial completion date • Trial primary completion date
|
Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
7ms
INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
P1, N=44, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
Enrollment closed
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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INO-5401 • rocakinogene sifuplasmid (INO-9012)
9ms
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, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Mar 2025 | Trial primary completion date: Dec 2025 --> Mar 2025
Trial completion • Trial completion date • Trial primary completion date
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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
9ms
CUE-102-01: A Phase 1 in Patients with HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (clinicaltrials.gov)
P1, N=42, Completed, Cue Biopharma | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
Trial completion • Trial completion date • Trial primary completion date
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WT1 (WT1 Transcription Factor) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
CUE-102
11ms
Combining a WT1 Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Diffuse Pleural Mesothelioma: A Phase 1 Study. (PubMed, JTO Clin Res Rep)
We enrolled patients with progressive or recurrent DPM treated with at least one course of pemetrexed-based chemotherapy. Median progression-free survival was 3.9 months and the median overall survival was 7.4 months. Coadministration of GPS and nivolumab reported a tolerable toxicity profile and induced immune responses in a subset of patients, but initial response and survival benefit were limited possibly owing to the small sample size.
P1 data • Journal • Checkpoint inhibition
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PD-L1 (Programmed death ligand 1) • WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • pemetrexed • Zeltherva (galinpepimut-S)
11ms
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 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
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