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Immunomodulator

Treatment (T-cell infusion, aldesleukin, utomilumab) for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Amir A Jazaeri
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 12 weeks up to 1 year
Awards & highlights

Study Summary

This trial is testing utomilumab in combination with T-cell infusion and aldesleukin to treat ovarian cancer.

Eligible Conditions
  • COL6A3 Positive Syndrome
  • HLA-A2 Positive Cells Present
  • Breast Cancer
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity Summary associated with Utomilumab Dose Escalation
Duration of in vivo persistence
Maximum Tolerated Dose (MTD) of T Cells
+1 more
Secondary outcome measures
Best overall response rate (BORR)
Progression free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (T-cell infusion, aldesleukin, utomilumab)Experimental Treatment5 Interventions
Patients undergo leukapheresis. Patients then receive cyclophosphamide IV on day -2, CD8-positive T-lymphocyte via infusion on day 0, and aldesleukin SC every 12 hours for 14 days. Beginning 24 hours after CD8-positive T-lymphocyte, patients also receive utomilumab IV over 90 minutes on days 1, 29, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Utomilumab
Not yet FDA approved
Aldesleukin
FDA approved
CD8-Positive T-Lymphocyte
2018
Completed Phase 2
~10
Cyclophosphamide
FDA approved
Leukapheresis
2016
Completed Phase 2
~690

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,291 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,264 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
278 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
T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer
2018. "T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03318900.
~1 spots leftby Apr 2025
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