P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Sol… (NCT05239143) | Clinical Trial Compass
Active — Not RecruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
United States180 participantsStarted 2022-02-15
Plain-language summary
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males or females, Subjects ≥18 years with life expectancy \>3 months
* Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer
* Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, and have measurable disease
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%
* Must have adequate vital organ function within pre-determined parameters
* Must have archived tumor tissue available or consent to a biopsy collection
* Must be willing to practice birth control
* Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration
* Must have recovered from toxicities due to prior therapies
Exclusion Criteria:
* Has inadequate venous access
* Has an active second malignancy (not disease free for at least 5 years) in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
* Is pregnant or lactating
* Has a history of or active autoimmune disease
* Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy
* Has an active systemic (viral, bacterial, or fungal) infection
* Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a histo…
What they're measuring
1
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Timeframe: Baseline through Day 28
2
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Timeframe: Baseline through 15 years
3
Evaluate the preliminary efficacy of P-MUC1C-ALLO1