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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)

NCT06660420 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Phase 1
  • Recurrent Melanoma
  • Refractory Melanoma

Interventions

DRUG

Cyclophosphamide

Given by IV

DRUG

Fludarabine

Given by IV

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Isabella C Glitza Oliva, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2029-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660420 on ClinicalTrials.gov