TerminatedPhase 1

CAR T Cells in Mesothelin-Expressing Breast Cancer

Stopped: Feasibility Concerns

United States2 participantsStarted 2023-02-06

Plain-language summary

Phase 1 - Safety and Proof of Concept

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with locally advanced unresectable or metastatic triple-negative breast cancer as confirmed by all of the following:
✓. ER-negative or low-ER positive (≤ 10% by IHC)
✓. PR-negative or low-PR positive (≤ 10% by IHC)
✓. HER2 negative by IHC/FISH
✓. Patients with an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
✓. Confirmed tumor mesothelin expression by ≥ 10% of malignant cells by IHC.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate organ and bone marrow function defined as:

✕. Active invasive cancer other than the study-targeted malignancy.
✕. Evidence of active hepatitis B or hepatitis C. The following would not qualify as an active infection, thus would not exclude the subject from participating:
✕. Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis for potential HBV reactivation.
✕. Positive HCV serology with quantitative PCR for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment.
✕. Patients with ongoing or active infection.
✕. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg/day of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
✕. Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (≤ 10mg daily equivalent of prednisone). Use of inhaled or topical steroids is allowable.
✕. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).

Occurrence of treatment-limiting toxicities (TLTs)

Timeframe: 90 days

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.

Timeframe: 15 years

NCT IDNCT05623488

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-07

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with locally advanced unresectable or metastatic triple-negative breast cancer as confirmed by all of the following:
✓. ER-negative or low-ER positive (≤ 10% by IHC)
✓. PR-negative or low-PR positive (≤ 10% by IHC)
✓. HER2 negative by IHC/FISH
✓. Patients with an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
✓. Confirmed tumor mesothelin expression by ≥ 10% of malignant cells by IHC.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate organ and bone marrow function defined as:

✕. Active invasive cancer other than the study-targeted malignancy.
✕. Evidence of active hepatitis B or hepatitis C. The following would not qualify as an active infection, thus would not exclude the subject from participating:
✕. Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis for potential HBV reactivation.
✕. Positive HCV serology with quantitative PCR for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment.
✕. Patients with ongoing or active infection.
✕. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg/day of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
✕. Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (≤ 10mg daily equivalent of prednisone). Use of inhaled or topical steroids is allowable.
✕. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).