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Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies

NCT07730125 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-08-07

No results posted yet for this study

Summary

The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are:

Phase 1

* Incidence of DLTs
* Incidence of CRG-150 related AEs and SAEs
* Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a
* HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment
* Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment

Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:

• CRG-150 cells at the assigned dose

Conditions

  • HR-positive, HER2-negative Breast Cancer
  • TNBC - Triple-Negative Breast Cancer
  • Prostate Cancer

Interventions

DRUG

CRG-150

autologous, gene-edited Treg cell therapy

Sponsors & Collaborators

Principal Investigators

  • Sonal Gupta, MD · CoRegen, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-06-30
Completion
2030-06-30
FDA Drug
Yes

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Entities

Diseases
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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 NCT07730125 on ClinicalTrials.gov