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MinorEligibility criteria expanded, about 14 wordsSite details revised at 2 of 16 sites · Publications: details revised at 7 of 8 entries · Study description expanded, about 4 wordsShow 3 more changesShow less
Site details revised at 2 of 16 sites
Publications: details revised at 7 of 8 entries
Study description expanded, about 4 words
NotableEnrollment increased: 200 → 500 participantsStudy description revised · Site contacts updated at 1 of 16 sitesv42Show 2 more changesShow less
NotablePrimary completion date: Dec 2025 to Dec 2028Study sites: 15 to 16 · Completion date: Dec 2026 to Apr 2029v38Show 2 more changesShow less
Study sites: 15 to 16
Completion date: Dec 2026 to Apr 2029
MinorStudy sites: 14 to 15v37
MinorSite contacts updated at 1 of 14 sitesv36
MinorSite details revised at 3 of 14 sitesv35
MinorRe-verified, no change to tracked fieldsv34
MinorStudy sites: 13 to 14v33
MinorSite contacts updated at 12 of 13 sitesv32
NotablePrimary completion date: Dec 2024 to Dec 2025Site contacts updated at 12 of 13 sitesv31Show 1 more changeShow less
Site contacts updated at 12 of 13 sites
MinorSite contacts updated at 1 of 13 sitesv30
MinorSite contacts updated at 1 of 13 sitesv29
MinorSite details revised at 3 of 13 sitesv28
MinorSite contacts updated at 1 of 13 sitesv27
MinorSite contacts updated at 3 of 13 sitesv26
MinorSite contacts updated at 2 of 13 sitesv25
MinorSite contacts updated at 2 of 13 sitesv24
MinorSite details revised at 1 of 13 sitesv23
MinorSite contacts updated at 1 of 13 sitesv22
MinorSite details revised at 1 of 13 sitesv21
MinorSite contacts updated at 1 of 13 sitesv20
MinorSite contacts updated at 1 of 13 sitesv19
MinorSite details revised at 6 of 13 sitesv18
MinorSite details revised at 1 of 13 sitesv17
MinorSite details revised at 1 of 13 sitesv16
NotablePrimary endpoints revised (2)Study sites: 8 to 13 · Interventions: Leukapheresis (Other), Long Range NGS HLA typing (Diagnostic Test), Next Generation Sequencing (NGS) (Diagnostic Test) to Apheresis (Other), Long Range NGS HLA typing (Diagnostic Test), Next Generation Sequencing (NGS) (Diagnostic Test) · Secondary endpoint revised · 3 morev15Show 6 more changesShow less
Study sites: 8 to 13
Interventions: Leukapheresis (Other), Long Range NGS HLA typing (Diagnostic Test), Next Generation Sequencing (NGS) (Diagnostic Test) to Apheresis (Other), Long Range NGS HLA typing (Diagnostic Test), Next Generation Sequencing (NGS) (Diagnostic Test)
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Nov 2021 to Oct 29, 2021 · Site details revised at 5 of 5 sitesv3Show 2 more changesShow less
Start date changed from estimate of Nov 2021 to Oct 29, 2021
Site details revised at 5 of 5 sites
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.
Design:
This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.