Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies (NCT07730125) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
67 participantsStarted 2026-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since CRG-150 is a gene-edited T regulatory cell therapy being tested for the first time in humans at this Phase 1/2 stage, what does that mean for how much we actually know about its safety and whether it might work for my specific cancer type?
2The trial is measuring dose-limiting toxicities within the first 28 days after infusion — what kinds of side effects are researchers watching for with this type of gene-edited cell therapy, and how would those be managed if they occurred?
3This trial hasn't started enrolling yet, so realistically how long might it be before I could even be considered, and is waiting for it a reasonable option given where my cancer stands right now?
4Given that this trial covers HR-positive HER2-negative breast cancer, triple-negative breast cancer, and prostate cancer all together, how does my specific diagnosis fit into how doses and safety are being evaluated, and does that affect what I might expect?
5Before considering a trial like this, are there standard or approved treatments I haven't tried yet that my care team would recommend first, or does my relapsed or refractory status make this kind of early-phase trial worth discussing sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with DLTs within 28 days from first infusion and overall safety
Timeframe: *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years
2
Determine the recommended phase 2 dose (RP2D) of CRG-150
. 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.
. Clinically significant, active, uncontrolled, systemic infection; the following are not exclusionary:
. 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.