Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With … (NCT05478837) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma
United States12 participantsStarted 2023-07-20
Plain-language summary
This phase I, first-in-human trial tests the safety, side effects, and best dose of genetically modified cells called KIND T cells after lymphodepletion (a short dose of chemotherapy) in treating patients who are HLA-A\*0201-positive and have H3.3K27M-mutated diffuse midline glioma. KIND T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory into KIND T cells so they will recognize certain markers found in tumor cells. Drugs such as cyclophosphamide and fludarabine are chemotherapy drugs used to decrease the number of T cells in the body to make room for KIND T cells. Giving KIND T cells after cyclophosphamide and fludarabine may be more useful against cancer compared to the usual treatment for patients with H3.3K27M-mutated diffuse midline glioma (DMG).
Who can participate
Age range2 Years – 25 Years
SexALL
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:
* Participants 2 to 25 years of age inclusive, at the time of signing the informed consent. The first two participants will be 12-25 years of age.
* Male participants of impregnate potential must agree to use contraception, during the study and for at least 6 months after the last study intervention and refrain from donating sperm during this period.
* Female participants of childbearing potential must agree to follow the contraceptive guidance, during the study and for at least 6 months after the last study intervention.
* Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days of receiving study interventions.
* CNS reservoir such as Ommaya catheter must be in place.
* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC018 if PNOC COMP is open to accrual at the enrolling institution.
* Participants with DMG who are positive for the H3.3K27M mutation (positive testing from a Clinical Laboratory Improvement Amendments (CLIA) laboratory required or equivalent) and who completed at least standard radiation therapy.
* All participants must test positive for HLA-A\*0201 (positive testing from a CLIA or equivalent laboratory required). Other HLA-A2 subtypes are excluded.
* All participants must consent for tumor tissue (fresh or archival) for biomarker analysis if available.
* All participants must have evaluable or measurable disease at the time of consent.
* All participants must be either off system…
What they're measuring
1
Frequency and severity of adverse events
Timeframe: Up to 28 days following infusion of autologous anti-H3.3K27M TCR-expressing T-cells (KIND T cells)