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CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

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ClinicalTrials.gov Identifier: NCT04660929
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Carisma Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE February 2, 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • 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 ]
    Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)
  • Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. [ Time Frame: 12 months ]
    Percentage of products that pass release criteria among all manufactured products.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • 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 ]
    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.
  • Estimate progression-free survival (PFS). [ Time Frame: 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Official Title  ICMJE 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
Brief Summary 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2-positive
  • Adenocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Bladder Cancer
  • Breast Cancer
  • Breast Neoplasm
  • Carcinoma, Ductal
  • Carcinoma, Hepatocellular
  • Cancer
  • Lung Cancer, Non-Small-Cell
  • 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
  • Prostate Cancer
  • Head and Neck Cancer
  • Endometrial Cancer
  • Lung Cancer, Small Cell
Intervention  ICMJE Biological: CT-0508
anti-HER2 CAR macrophages
Study Arms  ICMJE Experimental: Group 1 and Group 2
Both 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.
Intervention: Biological: CT-0508
Publications * Klichinsky M, Ruella M, Shestova O, Lu XM, Best A, Zeeman M, Schmierer M, Gabrusiewicz K, Anderson NR, Petty NE, Cummins KD, Shen F, Shan X, Veliz K, Blouch K, Yashiro-Ohtani Y, Kenderian SS, Kim MY, O'Connor RS, Wallace SR, Kozlowski MS, Marchione DM, Shestov M, Garcia BA, June CH, Gill S. Human chimeric antigen receptor macrophages for cancer immunotherapy. Nat Biotechnol. 2020 Aug;38(8):947-953. doi: 10.1038/s41587-020-0462-y. Epub 2020 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chief Medical Officer 267-491-6422 debora.barton@carismatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04660929
Other Study ID Numbers  ICMJE 101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carisma Therapeutics Inc
Study Sponsor  ICMJE Carisma Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Debora Barton, MD Carisma Therapeutics
PRS Account Carisma Therapeutics Inc
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP