Phase 1 Study of CD8+ T Cells for Leptomeningeal Melanoma
This Phase 1 study is testing a treatment called CD8+ T cells for people with leptomeningeal melanoma. Leptomeningeal melanoma is when melanoma cancer cells spread to the fluid and tissues surrounding the brain and spinal cord. The CD8+ T cells are taken from your own body, specially prepared, and then given back to you through an infusion. Researchers want to see how safe this treatment is and what side effects it might cause. They will also look at how long these special T cells stay in your body and if they help fight the cancer. This study is for adults aged 18 and older who have been diagnosed with leptomeningeal melanoma. The study plans to enroll up to 8 participants.
- Study design
- This is a Phase 1 study, meaning it's an early-stage trial focused on safety. It is a single-arm study, which means all participants receive the same treatment, and plans to enroll up to 8 individuals.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and side effects through study completion, which is an average of one year. Overall survival will also be evaluated for up to one year after the end of patient monitoring.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07414979
Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~8 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:CD8+T cells
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Isabella Glitza, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 8. 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. 9. Reproductive Status
Investigators shall counsel women of childbearing potential participants, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. The investigator shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
Local laws and regulations may require the use of alternative and/or additional contraception methods.
Female participants must have documented proof that they are not of childbearing potential.
Note: Women who are not of childbearing potential are exempt from contraceptive requirements.
WOCBP must have a negative highly sensitive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention. An extension up to 72 hours prior to start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to potentially decrease the risk for inclusion of a woman with an undetected pregnancy.
WOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.
WOCBP are permitted to use hormonal contraception methods. A female participant is eligible to participate if she is not pregnant or breastfeeding.
Patients may receive steroids to control symptoms related to CNS involvement, but the dose must be ≤ 4 mg per 24 hours of dexamethasone (or the equivalent). Patient's symptoms should experience stability of neurological symptoms for at least 7 days and without increasing needs for steroids. Physiologic replacement doses for adrenal insufficiency are allowed on this protocol but should not exceed 40 mg of hydrocortisone daily (or its equivalent).
Patients who have been treated with an approved targeted therapy (BRAF inhibitor and/or MEK inhibitor) will be allowed to remain on concurrent approved targeted therapy.
Patients who have received an approved systemic biologic therapy (e.g., antiPD-1, anti-CTLA4, IL-2, interferon) must have received their last treatment ≥ 2 weeks prior to the start of treatment with IT ECT, but can continue with treatment of anti-PD1 and/or CTLA-4
Treatment with anti-epileptics is allowed while on protocol.
No other concomitant intrathecal therapy with another agent will be allowed. 11. 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.
Patients that received previous IT therapy must have received their last treatment ≥ 7 days prior to the start of treatment with IT ECT.
Patients who have received systemic chemotherapy must have received their last treatment ≥ 14 days prior to the start of treatment with IT ECT.
Patients who have received an approved systemic biologic therapy (e.g., antiPD-1, anti-CTLA4, IL-2, interferon) must have received their last treatment ≥ 2 weeks prior to the start of treatment with IT ECT, but can continue with treatment of anti-PD1 and/or CTLA-4 (see exclusion paragraph)
Patients who have received any other investigational agents must have received their last treatment ≥ 14 days prior to the start of treatment with IT ECT.
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0