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

Conditions

• Leptomeningeal Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CD8+T cells — DRUG
  Given by infusion

Study Details

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.

Key Dates

Start date

Aug 31, 2026

Status verified

Feb 2026

Primary completion

Mar 22, 2028

Completion

Mar 22, 2030

Study Design

Enrollment

8 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: IT-ETC: Treatment with CD8+ T-cells (IT) Q4W
  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. On Cycle 1 Day 1 and Cycle 1 Day 15, patients will receive an intrathecal infusion of TAA-specific T cells. The patients will receive \~300 (150-300) million cells on Cycle 1 Day 1 and \~1000 (750-1000) million cells on Cycle 1Day 15.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Isabella Glitza, MD, PHD
  (713) 792-2921
  [email protected]

Locations (1)

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