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
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.
HR+HER2- breast cancer
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.
Sequential
CRG-150
Drugautologous, gene-edited Treg cell therapy
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
Determine the recommended phase 2 dose (RP2D) of CRG-150
RP2D, as determined through the dose escalation process for the specified indications
Cellular Kinetics: Presence, frequency, persistence and expansion of CRG-150 after infusion, by ddPCR
Patients will be monitored for expansion and persistence of CRG-150 after infusion by ddPCR analysis..
Efficacy: ORR in r/r HR+HER2- breast cancer and TNBC
The ORR is defined as the proportion of patients in CR or PR per RECIST 1.1 from the start of CRG-150 infusion until disease progression or initiation of new anticancer therapy.
Efficacy: ORR in r/r prostate cancer
ORR is defined as the proportion of patients in CR or PR per PCWG3-modified RECIST 1.1 criteria prior to disease progression or the initiation of new anticancer therapy
Click on the lead sponsor to view all of their trials.
CoRegen, Inc.
Lead sponsor
Baylor College of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
