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Phase 1 Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cell In Patients With Oral Premalignant Lesions

NCT07631013 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-11

No results posted yet for this study

Summary

This is a phase 1, single-arm, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of TGFBR2 TROP2 CAR/IL15 NK cells in patients with high-risk oral premalignant lesions.

Conditions

Interventions

DRUG

TROP2 CAR/IL-15 TGFBR2 KO NK cells

Participants will receive one of two doses of TROP2 CAR/IL-15 TGFBR2 KO NK injection on D0 and every three weeks thereafter, receive up to a total of 4 cycles at either dose.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Moran Amit, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07631013 on ClinicalTrials.gov