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

NCT07730125 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CoReg-001
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Phase 1/2a observational 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

Keywords

HR+HER2-Breast Cancer; Triple Negative Breast Cancer; TNBC; Prostate Cancer; relapsed/refractory; Treg; cell therapy; T Regulatory Cells; gene-edited; relapsed/refractory malignancies; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with DLTs within 28 days from first infusion and overall safety

  * The proportion of patients with DLTs occurring within 28 days from first cell infusion will be calculated for each dose level * Overall safety: type, frequency, and severity of SAEs (IRRs, immune reactions, new malignancies, AEs leading to death, and DLTs), and of treatment-related AEs and systemic reactions

  *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years

• Determine the recommended phase 2 dose (RP2D) of CRG-150

  RP2D, as determined through the dose escalation process for the specified indications

  Up to 1-year post-infusion

Secondary Outcomes (3)

• Cellular Kinetics: Presence, frequency, persistence and expansion of CRG-150 after infusion, by ddPCR

  Expansion up to 12 months post-infusion with CRG-150; Persistence: up to 5 years after infusion with CRG-150

• Efficacy: ORR in r/r HR+HER2- breast cancer and TNBC

  Up to 12 months post-infusion of CRG-150

• Efficacy: ORR in r/r prostate cancer

  Up to 12 months post-infusion with CRG-150

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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)

Drug: CRG-150

Interventions

CRG-150 DRUG

autologous, gene-edited Treg cell therapy

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding, and willing to comply with, and voluntarily sign and date an informed consent form (ICF).
• Willing to adhere to the study visit schedule and other protocol requirements, including the required apheresis procedure/blood collection.
• Is ≥18 years old at the time consent is obtained.
• Must have one of the following metastatic cancer diagnoses:
• HR+HER2- breast cancer
• TNBC
• Prostate cancer
• Has received the following treatment lines for their disease, and in the opinion of the Investigator, the patient would unlikely tolerate or derive clinically meaningful benefit from available treatment options:
• Metastatic HR+HER2- breast cancer
• Patients previously treated for metastatic disease with at least two of the following: endocrine therapy (ET), CDK4/6 inhibitors, or antibody-drug conjugate, with disease progression or intolerance to therapy.
• Prior chemotherapy is not required but does not exclude the patient from the study.
• Metastatic TNBC (mTNBC, estrogen, progesterone, and human epidermal growth factor receptor 2 \[HER2\] negative)
• Patients previously treated for metastatic disease with at least two of the following: immunotherapy, antibody-drug conjugate, or chemotherapy with disease progression or intolerance to therapy.
• Metastatic prostate cancer (mPC)
• Previously treated for advanced or metastatic disease with the following, alone or in combination, and have demonstrated disease progression by PCWG3 and/or RECIST 1.1 by Investigator judgment, OR is intolerant to therapy:

You may not qualify if:

• On systemic corticosteroid therapy (\>5 mg prednisone daily or its equivalent) for an underlying condition (if they were receiving corticosteroid therapy (\>5 mg prednisone daily or its equivalent), it must have been stopped \>7 days prior to apheresis for cell manufacturing). Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.
• Previous treatment with any investigational agent within 14 days of Screening Period.
• Has an active autoimmune disease (including but not limited to systemic lupus erythematosus, Sjögren's Syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 12 months (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Active malignancies other than the primary cancer indication, other than non-melanoma skin cancer or carcinoma-in-situ (cervix, bladder, or breast). Patients may be eligible if they have shown no evidence of active disease for two years prior to the first dose of the study drug.
• Patients with human immunodeficiency virus (HIV) must have been on effective antiretroviral therapy for ≥4 weeks prior to enrollment; must have an HIV viral load below the limits of detection; no acquired immunodeficiency syndrome-related opportunistic infections in the past 12 months; and a cluster of differentiation (CD)4+ cell count ≥350 cells/µL.
• Patients with chronic hepatitis B virus (HBV) infection must be on antiviral therapy and have an HBV viral load below the limits of detection.
• Patients with chronic hepatitis C virus (HCV) infection must have completed therapy and have an HCV viral load below the limits of detection.
• Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to screening, or no recovery from side effects of such intervention, or has planned elective surgery.
• Presence of active and clinically relevant central nervous system disorder, such as epilepsy, stroke, or symptomatic or uncontrolled brain metastases.
• Patients with severe chronic diseases of the kidney, liver, heart, lung, or any other serious illness that, in the opinion of the Investigator, may affect the patient's therapies, follow up, or assessments, including but not limited to uncontrolled clinically significant neurological or psychiatric disorders or metabolic diseases.
• Has significant cardiac disease, such as recent (within 6 months prior to first dose of the study drug) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias, or severe aortic stenosis.
• Has a history of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within 6 months prior to the first dose of the study drug.
• Patients with deep vein thrombosis or pulmonary embolism initially diagnosed within 6 months prior to the first dose of the study drug may be eligible if they are appropriately treated with anticoagulants (or are off anticoagulants if no longer indicated) and have no evidence of such disease at Screening.
• Has mental or medical conditions that prevent the patient from giving informed consent or participating in the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study.
• Has known or suspected intolerance to the components of the study drug, such as dimethyl sulfoxide.

Sponsors & Collaborators

• CoRegen, Inc.: lead
• Baylor College of Medicine: collaborator

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Prostatic Neoplasms; Recurrence; Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sonal Gupta, MD

  CoRegen, Inc.

  STUDY DIRECTOR

Central Study Contacts

Kerry VP, Clinical Operations

CONTACT

1-401-651-2920; KBiron@coregen.com

Suzanne Director, Clinical Operations

CONTACT

spetrossian@coregen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 * Dose levels 1, 2 and 3 (28-d dose-limiting toxicity (DLT) safety interval between dosing of the first participant and the next participant in each dose level cohort) Safety Review Committee (SRC) will review all available safety, efficacy and biomarker data to determine whether dose escalation should proceed to the next level * Proposed RP2D cohort * Optional backfill cohorts Phase 2a * Tumor-specific cohort expansion at the RP2D established from Phase 1 (No dose staggering required between participants) Phase 2a participants will be managed in an outpatient setting (with post-infusion observation of at least 4 hours)

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07