A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers

Overview

The study is comprised of two parallel Phase 1 Arms (solid tumors and multiple myeloma) and a Phase 1a expansion in patients with TnMUC1+ platinum-resistant ovarian cancer.

The Phase 1 portion of the study is designed to identify the dose and regimen of CART-TnMUC1 cells that can be safely administered intravenously following the lymphodepletion regimen to patients with (1) advanced TnMUC1+ solid tumors or (2) advanced TnMUC1+ multiple myeloma in a parallel two-arm Phase 1 dose escalation study. It is anticipated that approximately 40 patients will enroll in the Phase 1 dose escalation.

The Phase 1a expansion portion of the study is a single arm study designed to assess the preliminary efficacy of CART-TnMUC1 cells administered intravenously following the lymphodepletion regimen to patients with TnMUC1+ platinum-resistant ovarian cancer. It is anticipated that approximately 40 patients will enroll in the Phase 1a expansion.

SparkCures ID 1034
Trial Phase Phase 1
Enrollment 80 Patients
Treatments
Trial Sponsors
  • Tmunity Therapeutics Inc.
NCT Identifier

NCT04025216

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Key Inclusion Criteria:

  • Confirmed diagnosis of metastatic treatment-resistant ovarian cancer (including cancers of the fallopian tube), pancreatic adenocarcinoma, hormone receptor (HR)-negative and HER2-negative (triple negative) breast cancer (TNBC) or non-small cell lung cancer (NSCLC), or relapsed/refractory multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Prior therapies as defined by tumor type: Multiple myeloma: relapsed or refractory disease previously treated with at least three different lines of therapy; NSCLC: received standard therapy including both checkpoint inhibition and platinum-based chemotherapy; Pancreatic adenocarcinoma: disease progression following at least one standard of care systemic chemotherapy; TNBC: disease progression following at least one prior systemic anti-cancer therapy regimen; patients with PD-L1-positive disease must have received a PD-L1 or PD-1 pathway inhibitor; Ovarian: platinum-resistant and must have received at least two lines of therapy for metastatic disease
  • Evaluable disease as defined by tumor type
  • TnMUC1+ disease, determined by centrally tested TnMUC1 expression in a prior or archival tumor biopsy
  • Completed prior anti-cancer therapy at least 2 weeks prior to Screening and toxicities from any previous therapy must have recovered to grade 1 or 0
  • Life expectancy greater than 3 months
  • Serum creatinine ≤ 1.2 mg/dL or calculated creatinine clearance ≥ 60 ml/min (using the Cockcroft-Gault formula)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper institutional limit of normal with the following exception: Patients with known hepatic metastases, AST or ALT ≤ 3 x upper institutional limit of normal
  • Serum total bilirubin < 1.5 mg/dL with the following exception: patients with known Gilbert's disease, serum total bilirubin < 3 mg/dL
  • Serum albumin ≥ 3.0 g/dL (solid tumor patients in Arm 1 and Phase 1a only, not applicable to patients with multiple myeloma)
  • Left ventricular ejection fraction (LVEF) ≥ 50%. LVEF assessment must have been performed within 8 weeks of screening
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1500/μL
  • Platelet count ≥ 100,000/μL (≥ 30,000/μL if bone marrow plasma cells are ≥ 50% of cellularity for myeloma patients)
  • Absolute lymphocyte count of > 500/μL

Key Exclusion Criteria:

  • Active invasive cancer other than the proposed cancers included in the study
  • Current treatment with systemic high-dose corticosteroids (defined as a dose greater than the equivalent of prednisone 20 mg/day)
  • Active autoimmune disease (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease or multiple sclerosis) or have a history of severe autoimmune disease requiring prolonged immunosuppressive therapy (any immunosuppressive therapy should have been stopped within 6 weeks prior to screening visit)
  • Current, active human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infections
  • Prior allogeneic stem cell transplant
  • Active and untreated central nervous system (CNS) malignancy
  • History of severe infusion reaction to monoclonal antibodies or biological therapies, or to study product excipients that would preclude the patient safely receiving CART-TnMUC1 cells
  • Active or recent (within the past 6 months prior to apheresis) cardiac disease, defined as (1) New York Heart Association (NYHA) Class III or IV heart failure, (2) unstable angina or (3) a history of recent (within 6 months) myocardial infarction or sustained (> 30 second) ventricular tachyarrhythmias
  • Have inadequate venous access for or contraindications for the apheresis procedure
  • Pregnant or breastfeeding women

Key Inclusion Criteria:

  • Confirmed diagnosis of metastatic treatment-resistant ovarian cancer (including cancers of the fallopian tube), pancreatic adenocarcinoma, hormone receptor (HR)-negative and HER2-negative (triple negative) breast cancer (TNBC) or non-small cell lung cancer (NSCLC), or relapsed/refractory multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Prior therapies as defined by tumor type: Multiple myeloma: relapsed or refractory disease previously treated with at least three different lines of therapy; NSCLC: received standard therapy including both checkpoint inhibition and platinum-based chemotherapy; Pancreatic adenocarcinoma: disease progression following at least one standard of care systemic chemotherapy; TNBC: disease progression following at least one prior systemic anti-cancer therapy regimen; patients with PD-L1-positive disease must have received a PD-L1 or PD-1 pathway inhibitor; Ovarian: platinum-resistant and must have received at least two lines of therapy for metastatic disease
  • Evaluable disease as defined by tumor type
  • TnMUC1+ disease, determined by centrally tested TnMUC1 expression in a prior or archival tumor biopsy
  • Completed prior anti-cancer therapy at least 2 weeks prior to Screening and toxicities from any previous therapy must have recovered to grade 1 or 0
  • Life expectancy greater than 3 months
  • Serum creatinine ≤ 1.2 mg/dL or calculated creatinine clearance ≥ 60 ml/min (using the Cockcroft-Gault formula)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper institutional limit of normal with the following exception: Patients with known hepatic metastases, AST or ALT ≤ 3 x upper institutional limit of normal
  • Serum total bilirubin < 1.5 mg/dL with the following exception: patients with known Gilbert's disease, serum total bilirubin < 3 mg/dL
  • Serum albumin ≥ 3.0 g/dL (solid tumor patients in Arm 1 and Phase 1a only, not applicable to patients with multiple myeloma)
  • Left ventricular ejection fraction (LVEF) ≥ 50%. LVEF assessment must have been performed within 8 weeks of screening
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1500/μL
  • Platelet count ≥ 100,000/μL (≥ 30,000/μL if bone marrow plasma cells are ≥ 50% of cellularity for myeloma patients)
  • Absolute lymphocyte count of > 500/μL

Key Exclusion Criteria:

  • Active invasive cancer other than the proposed cancers included in the study
  • Current treatment with systemic high-dose corticosteroids (defined as a dose greater than the equivalent of prednisone 20 mg/day)
  • Active autoimmune disease (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease or multiple sclerosis) or have a history of severe autoimmune disease requiring prolonged immunosuppressive therapy (any immunosuppressive therapy should have been stopped within 6 weeks prior to screening visit)
  • Current, active human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infections
  • Prior allogeneic stem cell transplant
  • Active and untreated central nervous system (CNS) malignancy
  • History of severe infusion reaction to monoclonal antibodies or biological therapies, or to study product excipients that would preclude the patient safely receiving CART-TnMUC1 cells
  • Active or recent (within the past 6 months prior to apheresis) cardiac disease, defined as (1) New York Heart Association (NYHA) Class III or IV heart failure, (2) unstable angina or (3) a history of recent (within 6 months) myocardial infarction or sustained (> 30 second) ventricular tachyarrhythmias
  • Have inadequate venous access for or contraindications for the apheresis procedure
  • Pregnant or breastfeeding women

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

The Angeles Clinic and Research Institute

Los Angeles, CA

California
The Angeles Clinic and Research Institute

Los Angeles, CA

Pennsylvania

Resources

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