Autologous CD8+ Melanoma Specific T Cells for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Melanoma+2 More
Autologous CD8+ Melanoma Specific T Cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well white blood cells taken from a person's own body, when mixed with other drugs, work in treating patients with melanoma that has spread to another place in the body.

Eligible Conditions
  • Melanoma
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Metastatic Melanoma

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 5 years

Up to 12 weeks
Overall response
Up to 5 years
Incidence of toxicity

Trial Safety

Trial Design

1 Treatment Group

Treatment (T cells, chemo, aldesleukin, ipilimumab)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Autologous CD8+ Melanoma Specific T Cells · No Placebo Group · Phase 2

Treatment (T cells, chemo, aldesleukin, ipilimumab)Experimental Group · 5 Interventions: Ipilimumab, Cyclophosphamide, Autologous CD8+ Melanoma Specific T Cells, Aldesleukin, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Biological, Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Cyclophosphamide
FDA approved
Aldesleukin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,897 Total Patients Enrolled
543 Trials studying Melanoma
356,888 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterLead Sponsor
2,783 Previous Clinical Trials
1,784,828 Total Patients Enrolled
98 Trials studying Melanoma
25,411 Patients Enrolled for Melanoma
Adi DiabPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Melanoma
75 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Expression of HLA-A2.
You are a male and you are willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if your sexual partners are WOCBP.
You have melanoma and you have metastatic disease.
Consider PICC or central line for venous access.
You have a performance status of '0-1' at screening visit.
Tumor size is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.