Immune cells injected into spine to fight brain cancer
NCT ID NCT07414979
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This early-phase trial tests whether immune cells (CD8+ T cells) given through a spinal tap are safe for people with melanoma that has spread to the lining of the brain. Only 8 participants will receive the treatment. The main goal is to check for side effects, not to cure the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD8+ T cells (immune cells)
- What this could lead to
- If it works, this could point toward a new way to treat melanoma that has spread to the brain lining.
- What could go wrong
- This is a very early, small trial (8 people) focused on safety, not effectiveness. The treatment may not work or could cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have radiographic and/or CSF cytological evidence of LMD. 2. 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. 3. Male or female subjects ≥18 years of age. 4. Expression of HLA-A2 or HLA-A24. 5. ECOG/ Zubrod performance status ≤1 at screening visit for this treatment 6. Ability to understand and the willingness to sign a written informed consent document. 7. The effects of Endogenous T Cell (ETC) Therapy on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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: * 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. participant is eligible to participate if she is not pregnant or breastfeeding. 10. Concurrent Therapy * 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. Exclusion Criteria: 1. Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea. 2. All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ grade 1 or baseline) prior to study treatment administration. This excludes non-serious toxicities. However, stable endocrinopathies requiring replacement therapy will be allowed.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States