This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.
Age ≥ 21 years.
Phase I: HER2-positive breast or gastric cancer or other treatment-refractory HER2-positive solid tumors
Phase II : HER2-positive breast carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Treatment within the last 30 days with any investigational drug.
Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Major surgery within 28 days of study drug administration.
Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
Sequential
Chimeric receptor T-cells + Trastuzumab
DrugChimeric receptor T-cells will be administered by infusion. Trastuzumab will be administered intravenously.
Fludarabine and Cyclophosphosphamide
Drug3-day chemotherapy regimen of fludarabine and cyclophosphamide for lymphodepletion
Time to treatment failure
defined as the time from the date of study enrolment to the date of the first of the following events: early discontinuation of study therapy, progressive disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for patients who did not discontinue early, who are still alive, and who have not progressed.
Progression-free survival
is defined as the time from the date of study enrolment to the first date of documented disease progression. Progression-free survival will be censored at the date of death for patients who have not had documented disease progression. For patients who are still alive at the time of analysis and who have not had documented disease progression, progression-free survival will be censored at the date of the last follow-up visit.
Duration of tumour response
Among tumor responders, the duration of tumor response is measured from the date of enrolment until the first date of documented disease progression or death due to any cause, whichever occurs first. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.
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