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CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

NCT04660929Active, Not RecruitingPHASE1INTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Carisma Therapeutics Inc

Enrollment

Start Date

2021-02-02

Completion Date

2024-12-31

Study Type

INTERVENTIONAL

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

Interventions

CT-0508Pembrolizumab

Conditions

HER2-positiveAdenocarcinomaBile Duct CancerBiliary Tract CancerBladder CancerBreast CancerBreast NeoplasmCarcinomaDuctalCarcinomaHepatocellularCancerLung CancerNon-Small-CellCarcinomaOvarian EpithelialCarcinomaSmall CellCarcinomaSquamousCarcinomaTransitional CellColorectal CancerEsophagogastric Junction NeoplasmsInflammatory Breast CancerStomach NeoplasmsMalignant NeoplasmsOvarian NeoplasmsPancreatic CancerHER2-positive Solid TumorsHER2-positive Breast CancerHER2-positive Gastric CancerHER-2 Protein OverexpressionHER-2 Gene AmplificationProstate CancerHead and Neck CancerEndometrial CancerLung CancerSmall Cell

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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)

Time frame: 14 months

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.

Time frame: 12 months

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)

Time frame: 14 months

Secondary Outcomes

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.

Time frame: 24 months

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.

Time frame: 24 months

Locations

City of Hope National Medical Center, Duarte, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, United States

OHSU Knight Cancer Institute, Portland, United States

Abramson Cancer Center, Philadelphia, United States

Tennessee Oncology / Sarah Cannon Research Institute, Nashville, United States

M D Anderson Cancer Center, Houston, United States

Fred Hutchinson Cancer Center, Seattle, United States

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.