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CAR T-cell Therapy

Autologous NY-ESO-1-specific CD8-positive T Lymphocytes for Synovial Sarcoma

Phase 1
Waitlist Available
Led By Neeta Somaiah
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 168 days
Awards & highlights

Study Summary

This trial is testing how well a combination of autologous T cells, chemotherapy, and aldesleukin with or without LV305 and CMB305 works in treating sarcoma.

Eligible Conditions
  • Synovial Sarcoma
  • HLA-A2 Positive Cells Present
  • Cancer
  • Myxoid Liposarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 168 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of in vivo persistence of transferred T cells
The Laboratory abnormalities
The nature, frequency and severity of adverse events
Secondary outcome measures
Antigen-spreading
Differentiation phenotype
Persistence of cellular immune response
+1 more

Side effects data

From undefined Phase 1 trial • 2 Patients • NCT02319824
50%
Rash
50%
cough
50%
shortness of breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Radiation and NY-ESO-1-specific T Cells)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305)Experimental Treatment4 Interventions
Participants receive cyclophosphamide, autologous NY-ESO-1-specific CD8-positive T lymphocytes, and aldesleukin as in Cohort 0. Participants also receive dendritic cell-targeting lentiviral vector ID-LV305 ID on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
Group II: Cohort 0 (cyclophosphamide, T cells, aldesleukin)Experimental Treatment3 Interventions
Participants receive cyclophosphamide IV over 30-60 minutes on day -2 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV over 60 minutes on day 0. Then, 6 hours later and twice a day for 14 days, receive aldesleukin SC in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Dendritic Cell-targeting Lentiviral Vector ID-LV305
2018
Completed Phase 1
~20
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
2015
Completed Phase 1
~20
Aldesleukin
2012
Completed Phase 4
~1620

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,787 Total Patients Enrolled
1 Trials studying Synovial Sarcoma
44 Patients Enrolled for Synovial Sarcoma
Neeta SomaiahPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
111 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma
2018. "Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03450122.
~2 spots leftby Apr 2025
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