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CAR T-cell Therapy

Leukapheresis for Sarcoma (NYESO SCT Trial)

Phase 1
Waitlist Available
Led By Theodore Scott Nowicki, M.D.
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IV or locally advanced unresectable cancers for which no alternative therapies with proven survival advantage are available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

NYESO SCT Trial Summary

This trial is testing a new cancer treatment that replaces a patient's immune system with new cells that have been redirected to attack and kill cancer cells.

Eligible Conditions
  • Sarcoma
  • Malignant Neoplasm
  • Cancer
  • Malignant Tumor
  • HLA-A2 Positive Cells Present

NYESO SCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have an advanced cancer that cannot be removed by surgery and no other proven treatment options are available.

NYESO SCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicity
Secondary outcome measures
Detection of replication competent retrovirus and replication competent lentivirus
Duration of overall complete response
Duration of overall response
+8 more
Other outcome measures
Regional uptake of 18F-FHBG within metastatic tumor sites and secondary lymphoid organs

NYESO SCT Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Genetically engineered PBMC and PBSC)Experimental Treatment10 Interventions
G-CSF AND PLERIXAFOR MOBILIZED LEUKAPHERESIS: Between 6 months and 3 weeks before infusion of cells, patients undergo G-CSF and plerixafor mobilization of CD34+ peripheral blood stem cells. Patients receive G-CSF SC on mobilization days 1-8 and plerixafor SC on mobilization days 4-7. Patients also undergo an unmobilized leukapheresis on day -5 before infusion of cells. CHEMOTHERAPY CONDITIONING REGIMEN: Patients receive busulfan IV on days -4 to -2 and fludarabine IV over 30 minutes on days -3 to -2. Patients receive LV-NYESO TCR/sr39TK PBSC IV on day 0, and after approximately 24 hours, patients receive RV-NYESO TCR PBMC IV on day 1. Beginning on day 2, patients receive aldesleukin SC BID for up to 7 days. Patients undergo blood collection for safety and immune monitoring on days 0, 1, 3, 5, 7, 14, 30, 60, 90, and 120. Patients receive 18F-FHBG IV, and after 1 hour, undergo PET/CT on days 25 and 120.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2010
Completed Phase 2
~640
Fludarabine
2012
Completed Phase 3
~1090
Busulfan
2008
Completed Phase 3
~1120
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2008
Completed Phase 2
~2260
Filgrastim
2000
Completed Phase 3
~3670
Aldesleukin
2012
Completed Phase 4
~1620
Plerixafor
2011
Completed Phase 3
~720

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,071 Total Patients Enrolled
7 Trials studying Sarcoma
234 Patients Enrolled for Sarcoma
California Institute for Regenerative Medicine (CIRM)OTHER
62 Previous Clinical Trials
3,148 Total Patients Enrolled
Theodore Scott Nowicki, M.D.Principal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

NY-ESO-1 TCR Engineered PBMC and PBSC (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03240861 — Phase 1
Sarcoma Research Study Groups: Treatment (Genetically engineered PBMC and PBSC)
Sarcoma Clinical Trial 2023: NY-ESO-1 TCR Engineered PBMC and PBSC Highlights & Side Effects. Trial Name: NCT03240861 — Phase 1
NY-ESO-1 TCR Engineered PBMC and PBSC (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03240861 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of this research project's participants?

"Yes, the clinicaltrials.gov portal confirms that this medical study is searching for 12 participants from 1 trial site. The listing was first uploaded on July 26th 2017 and last modified on February 10th 2022."

Answered by AI

What health issues can be addressed through Cellular Therapy?

"Mobilization of hematopoietic stem cells is generally treated with Cellular Therapy, a method that has also been employed to manage bone marrow transplantation, leukemia and febrile neutropenia."

Answered by AI

What precedent is there for Cellular Therapy research?

"Presently, 563 Cell Therapy trials are underway. Of these, 62 have progressed to the third phase of clinical research. The majority of studies take place in Philadelphia, but 8628 other locations also conduct similar trials for this form of treatment."

Answered by AI

Can individuals still join this experiment?

"Indeed, the statistics on clinicaltrials.gov reveal that this medical research is actively recruiting individuals. This trial was initially posted in July 2017 and most recently updated in February 2022; 12 patients must be recruited from 1 centre."

Answered by AI

Has the Food & Drug Administration sanctioned Cellular Therapy?

"With limited evidence for both safety and efficacy, Cellular Therapy receives a score of 1."

Answered by AI
~1 spots leftby Mar 2025