33 results
This first-in-human study is planned to include both a dose ranging phase and a confirmatory phase, with the intention that all data collected throughout the study may support registration. The dose ranging phase will be conducted in cohorts of 3-4…
Primary Objectives• To characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) and define the Recommended Phase 2 Dose (RP2D) of WU-CART-007 in…
The primary objective of the phase 1a dose escalation was to assess the safety and to determine the maximum tolerated dose and the incidence of dose limiting toxicities (DLT) during the DLT period (infusion period of UniCAR02-T in combination with…
The primary objective of the study is to evaluate the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.In the phase I part of the study the main objective is to…
Primary-To evaluate the safety and tolerability of a single dose of EDIT-101 when administered to participants with LCA10-IVS26 mutationSecondary-To evaluate different doses of EDIT-101 for subsequent clinical evaluation-To evaluate the efficacy of…
Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…
Primary objectives for the dose-escalation part of the study: • To assess the safety and tolerability of HA-1H TCR transduced T cells (MDG1021) in patients with relapsed or persistent hematologic malignancies after allo-HSCT with or without…
Primary objective:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior…
Primary objective: To compare the efficacy of JNJ-68284528 with standard therapy, either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
• To characterize the safety and tolerability of one-time IT administered SBT101 in adults diagnosed with AMN.• To characterize the efficacy of IT administered SBT101 in adults diagnosed with AMN.• To assess the change in quality of life, patient…
To compare the efficacy of VRd followed by cilta-cel therapy versus VRd followed by Rd therapy in terms of progression free survival (PFS)
The purpose of this study is to characterize the safety and tolerability of OAV101 IT in participants who have discontinued treatment with nusinersen (Spinraza®) or risdiplam (Evrysdi®). The data from this study will expand on the data generated…
The primary objective is to compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy, in terms of progression-free survival (PFS) and sustained minimal…