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NCT ID: NCT05225259 No longer available - Clinical trials for Carcinoma, Non-Small-Cell Lung

Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor

Start date: n/a
Phase:
Study type: Expanded Access

Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor. The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.

NCT ID: NCT05235347 No longer available - Covid19 Clinical Trials

Sotrovimab Expanded Access Treatment Protocol (COVID-19)

Start date: n/a
Phase:
Study type: Expanded Access

An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.

NCT ID: NCT05317780 No longer available - Canavan Disease Clinical Trials

Canavan-Single Patient IND

Start date: n/a
Phase:
Study type: Expanded Access

A recombinant virus vector constructed from adeno-associated virus (AAV) has been engineered to carry the human aspartoacylase (ASPA) gene expressed from a modified CMV-enhancer chicken β-actin (CB6) promoter. The construct has been shown to produce ASPA in animal models of Canavan disease, which closely match the proposed human study. The proposed clinical trial is an open label, expanded access study administering rAAV9-CB6-AspA gene vector by simultaneous systemic and intracerebroventricular routes to a single human subject (18-24 months of age) with Canavan disease. The subject will also receive immune modulation to transiently ablate B-cells (Rituximab) and modulate T-cell response (Sirolimus) prior to the initial exposure to AAV9. Given the null AspA mutations of the subject and current AAV seronegative status, this regimen will allow for later exposure to the therapeutic vector if needed and block any immuno-toxicity in the CNS. The goal of this study is to measure the safety and efficacy of AAV-mediated gene therapy as a treatment approach for neuronal pathology in Canavan disease. The subject will act as their own control and change from baseline will be assessed in regards to levels of brain NAA, brain water content and morphology, improved clinical status and peripheral levels of NAA. Safety parameters measured in this study will include: serum chemistries and hematology, urinalysis, physical assessments, whole blood assay for vector genomes, immunologic response to ASPA and AAV, as well as reported subject symptom history.

NCT ID: NCT05392374 No longer available - Glioma Clinical Trials

Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas

Start date: n/a
Phase:
Study type: Expanded Access

This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.

NCT ID: NCT05398640 No longer available - Metastatic Melanoma Clinical Trials

Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

Start date: n/a
Phase:
Study type: Expanded Access

This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

NCT ID: NCT05415228 No longer available - Clinical trials for Prostate Adenocarcinoma

Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11). The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

NCT ID: NCT05483322 No longer available - Clinical trials for Frontotemporal Dementia

An Open-Label, Expanded Access Protocol of LAM-002A in C9ORF72-Associated Frontotemporal Dementia (FTD)

Start date: n/a
Phase:
Study type: Expanded Access

This is an open-label, single subject, expanded access protocol (EAP) of the LAM-002A investigational product administered orally at 125 mg BID for 52 weeks.

NCT ID: NCT05503550 No longer available - Clinical trials for Relapsed or Refractory Multiple Myeloma

Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.

NCT ID: NCT05505838 No longer available - Clinical trials for Transthyretin-mediated Amyloidosis With Cardiomyopathy

Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis With Cardiomyopathy

Start date: n/a
Phase:
Study type: Expanded Access

The objective of the study is to assess the long-term safety of patisiran in patients with ATTR amyloidosis with cardiomyopathy as assessed by a review of adverse events (AEs).

NCT ID: NCT05511350 No longer available - Clinical trials for Solid Tumor Metastatic Cancer Advanced Cancer

Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001

Start date: n/a
Phase:
Study type: Expanded Access

This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment.