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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04660929
Other study ID # 101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 2, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Carisma Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 Main Study - Group 1 and Group 2 all HER2 overexpressing solid tumors Intraperitoneal Substudy - HER2 overexpressing peritoneal disease 89[Zr] radiolabeled CT-0508 Substudy - All HER2 overexpressing solid tumors (Univ of Penn, Abramson Cancer Center only) CT-0508 Combination with Pembrolizumab Substudy - All HER2 overexpressing solid tumors


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. CT-0508 in Combination with Pembrolizumab Substudy Only: Exclusion Criteria: - Subjects with severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients - Subjects with an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). - Subjects who have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Subjects who have had an allogeneic tissue/solid organ transplant

Study Design


Related Conditions & MeSH terms

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

Intervention

Biological:
CT-0508
anti-HER2 CAR macrophages
Pembrolizumab
anti-PD antibody

Locations

Country Name City State
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States City of Hope National Medical Center Duarte California
United States M D Anderson Cancer Center Houston Texas
United States Tennessee Oncology / Sarah Cannon Research Institute Nashville Tennessee
United States Abramson Cancer Center Philadelphia Pennsylvania
United States OHSU Knight Cancer Institute Portland Oregon
United States Fred Hutchinson Cancer Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Carisma Therapeutics Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors. Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS) 14 months
Primary Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. Percentage of products that pass release criteria among all manufactured products. 12 months
Primary Assess the safety and tolerability of CT-0508 in combination with pembrolizumab by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors (CT-0508 and pembrolizumab substudy only) Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS) 14 months
Secondary 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. 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. 24 months
Secondary Estimate progression-free survival (PFS). 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.
24 months
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