NCT06660420

Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.

Detailed description

Primary Objectives 1\. To determine he safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PRAME-TCR-NK cells in participants with relapsed and/or refractory melanoma. Secondary Objectives 1. To determine preliminary antitumor activity of PRAME-TCR-NK cells in participants with relapsed and/or relapsed and/or refractory melanoma. 2. To quantify the persistence of infused allogeneic donor PRAME-TCR-MK cells in the peripheral blood of the recipient. 3. To evaluate tissue and blood-based biomarkers associated with response and resistance to PRAME-TCR-NK cell infusion.

Conditions

• Phase 1
• Recurrent Melanoma
• Refractory Melanoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given by IV
DRUG	Fludarabine	Given by IV

Timeline

• Start date: 2025-02-25
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2024-10-28
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study