Clinical trial · Interventional
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
NCT05239143CI-TRIAL-00102798active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P-MUC1C-ALLO1 CAR-T cells | Biological | — | UNRESOLVED |
| Rimiducid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)
- description
- * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-MUC1C-ALLO1 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
- label
- P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)
- description
- * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-MUC1C-ALLO1 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 history of myocardial infarction or significant arrhythmia * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has received anticancer medications within 2 weeks of the time of initiating lymphodepletion * Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study * Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study * Has known CNS metastases or symptomatic CNS involvement * Has a history of significant liver disease or active liver disease * Has a history of known genetic predisposition to HLH/MAS * Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy
References
Publications (1)
- DERIVEDGorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025. PMID 40443562