Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)

Part of paid clinical trials in Duarte, California.

Sponsor
Minerva Biotechnologies Corporation
Study ID
NCT04020575
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells — BIOLOGICAL
    huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head).
  • huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D — BIOLOGICAL
    huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head) @ RP2D

Study Details

Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).

Key Dates

First listed
Jul 16, 2019
Start date
Jan 15, 2020
Status verified
Jun 2023
Primary completion
Jan 31, 2025
Completion
Jan 15, 2035

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding.
  • Experimental: Luminal
    Dose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer.
  • Experimental: HER2+
    Dose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer.
  • Experimental: Triple Negative
    Dose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Within 35 days after T cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000
Joanne Mortimer, MD
800-826-4673
Joanne Mortimer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope Medical Center· Duarte, CA

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