Not Yet RecruitingPhase 1

Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma

United States8 participantsStarted 2026-08-31

Plain-language summary

The proposed study is a single arm Phase I trial aimed at treating up to 6 HLA-A\*0201+ and HLA-A\*24 02+ individuals with leptomeningeal disease from metastatic melanoma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must have radiographic and/or CSF cytological evidence of LMD.
. Must have a confirmed diagnosis of primary CNS melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal, or mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted.
. Male or female subjects ≥18 years of age.
. Expression of HLA-A2 or HLA-A24.
. ECOG/ Zubrod performance status ≤1 at screening visit for this treatment
. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Endogenous T Cell (ETC) Therapy administration.
. Reproductive Status
0. Concurrent Therapy
1. Washout periods from other therapies Patients who have received radiation to brain and/or spine, including whole brain radiation, stereotactic radiosurgery (SBRT), are eligible, but must have completed radiation treatment at least 7 days prior to the start of treatment with IT ECT.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT07414979

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-22

Contact for this trial

Isabella Glitza, MD, PHD

(713) 792-2921 icglitza@mdanderson.org

View on ClinicalTrials.gov More Leptomeningeal Melanoma trials