AVC-102 / AvenCell Therap - LARVOL DELTA

Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: AvenCell Europe GmbH | N=51 ➔ 16 | Trial completion date: Jul 2025 ➔ Mar 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Mar 2024; Although IMP has been well tolerated, biological activity was very limited. The sponsor concluded that continued development of IMP would be unlikely to result in meaningful clinical benefit for patients with prostate cancer.

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: AvenCell Europe GmbH | N=39 ➔ 51 | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2023 ➔ Dec 2024

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: AvenCell Europe GmbH | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Apr 2023 ➔ Jul 2023

Combination therapy • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

GEMoaB Announces Clinical Data Presentations on Their Lead Asset UniCAR-T-CD123 in relapsed/refractory AML at the Upcoming EHA-EBMT 3rd European CAR T-Cell Meeting (PRNewswire) - "GEMoaB...announced the acceptance of two presentations on clinical data from the ongoing Phase I study...at the 2021 EHA-EBMT 3rd European CAR T-Cell Meeting, being held from February 4-6...The UniCAR platform promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors...A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123, for the treatment of relapsed/refractory AML, is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors, has been initiated."

P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

GEMoaB Announces UniCAR-T-CD123 Data from its Ongoing Phase I Study in Patients with Relapsed/Refractory AML (rrAML) to be Presented at Virtual 3rd EHA-EBMT European CAR T-Cell Meeting (PRNewswire) - P1, N=45; NCT04230265; Sponsor: Cellex Patient Treatment GmbH; "GEMoaB...announced interim data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the Virtual 3rd EHA-EBMT European CAR-T-Cell Meeting, which is held from February 04-06, 2021...UniCAR-T-CD123 has been well tolerated to date with CRS (cytokine release syndrome) grade 1-2; no ICU admissions or dose limiting toxicities have been observed by the cut-off date; UniCAR-T-CD123 dose escalation is ongoing....Phase IA dose-finding studies of the first UniCAR assets UniCAR-T-CD123 in hematological malignancies and UniCAR-T-PSMA in solid tumors are currently recruiting patients."

Cytokine release syndrome • Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

Initiation of First UniCAR Cellular Immunotherapy Study in Advanced Solid Tumors (PRNewswire) - “GEMoaB…announced that it has apheresed the first patient in a Phase IA study with UniCAR-T-PSMA, the lead solid tumor product candidate from its proprietary UniCAR cellular immunotherapy platform….The Phase IA study includes patients with late-stage PSMA-positive relapsed/refractory solid tumors such as Castrate Resistant Prostate Cancer (CRPC), Non-small Cell Lung Cancer (NSCLC) or Triple Negative Breast Cancer (TNBC).”

Trial status • Breast Cancer • Genito-urinary Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer