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

Sponsor
CoRegen, Inc.
Study ID
NCT07730125
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRG-150 — DRUG
    autologous, gene-edited Treg cell therapy

Study Details

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

Key Dates

First listed
Jul 28, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Drug: CRG-150 autologous cell therapy 3 escalating dose levels with 2 de-escalation dose levels are designed to explore the safety, tolerability, cellular kinetics and antitumor activity of CRG-150. DL-1: 50 x 10e6 cells (de-escalation) DL1: 75 x 10e6 cells DL2: 375 x 10e6 cells DL2.5 (optional): 562 x 10e6 cells (de-escalation) DL3: 750 x 10e6 cells Phase 2 expansion at RP2D: in HR+HER2- breast cancer, TNBC and/or Prostate Cancer. (10 participants per tumor type)

Primary Outcome Measure

Proportion of patients with DLTs within 28 days from first infusion and overall safety [ Time Frame: *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years ]

Central Contacts

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