Clinical Trials /

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

NCT04660929

Description:

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
  • Official Title: A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 101
  • NCT ID: NCT04660929

Conditions

  • HER2-positive
  • Adenocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Bladder Cancer
  • Breast Cancer
  • Breast Neoplasm
  • Carcinoma, Ductal
  • Carcinoma, Hepatocellular
  • Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Small Cell
  • Carcinoma, Squamous
  • Carcinoma, Transitional Cell
  • Colorectal Cancer
  • Esophagogastric Junction Neoplasms
  • Inflammatory Breast Cancer
  • Stomach Neoplasms
  • Malignant Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Cancer
  • HER2-positive Solid Tumors
  • HER2-positive Breast Cancer
  • HER2-positive Gastric Cancer
  • HER-2 Protein Overexpression
  • HER-2 Gene Amplification

Interventions

DrugSynonymsArms
CT-0508Group 1 and Group 2

Purpose

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Detailed Description

      A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered
      to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid
      Tumors
    

Trial Arms

NameTypeDescriptionInterventions
Group 1 and Group 2ExperimentalBoth groups will receive the full dose manufactured per patient. Group 1 will undergo intra subject dose escalation of IV administrations of up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5. Group 2 will receive the full dose IV on Day 1 of up to 5 billion cells.
  • CT-0508

Eligibility Criteria

        Inclusion Criteria:

          -  HER2-positive recurrent or metastatic solid tumors for which there are no available
             curative treatment options.

               -  Breast cancer and gastric/gastroesophageal junction cancers must have failed
                  approved HER2-targeted agents.

               -  Other HER2-positive tumor types must have failed standard of care therapies,
                  while prior therapy with anti-HER2 drugs is not required.

          -  Subject must be willing and able to undergo tumor tissue biopsy procedures

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Subject has adequate bone marrow and organ function

        Exclusion Criteria:

          -  HIV, active hepatitis B or hepatitis C infection.

          -  Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy
             or any other form of immunosuppressive therapy

          -  Untreated or symptomatic central nervous system (CNS) metastases or cytology proven
             carcinomatous meningitis.

             o Subjects with small, asymptomatic CNS metastases that do not require treatment are
             permitted to enroll.

          -  Left ventricular ejection fraction (LVEF) <50% as determined by ECHO or multiple gated
             acquisition scan (MUGA)

        Other protocol-defined Inclusion/Exclusion may apply.

        -
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.
Time Frame:14 months
Safety Issue:
Description:Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)

Secondary Outcome Measures

Measure:Estimate the objective response rate (ORR), according to RECIST v1.1, of at least 1 dose of CT-0508 among subjects with HER2 overexpressing solid tumors.
Time Frame:24 months
Safety Issue:
Description:Proportion of subjects with an objective response (either a complete response [CR] or partial response [PR]) in subjects who received at least 1 dose of CT-0508 and at least the 8-week tumor evaluation as determined by the investigator using RECIST v1.1.
Measure:Estimate progression-free survival (PFS).
Time Frame:24 months
Safety Issue:
Description:Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first. Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Carisma Therapeutics Inc

Trial Keywords

  • HER2-positive solid tumors
  • Phase 1
  • cell therapy
  • CAR-macrophage
  • immunotherapy
  • advanced cancer
  • post menopausal
  • premenopausal
  • metastatic cancer

Last Updated

December 9, 2020