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Recruiting NCT06347068

Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

Phase I Interventional Breast Cancer Relapse Resistant Cancer Triple Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iC9-CAR.B7-H3 T Cell Therapy, cyclophosphamide, fludarabine.
Who it may be relevant to
Registry conditions: Breast Cancer, Relapse, Resistant Cancer, Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer

Overview

This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).

Detailed description

T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) treatment is experimental and has not been approved by the Food and Drug Administration. The safety of iC9-CAR.B7-H3 T cells will be investigated using a modified 3+3 design. The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD) and additional factors such as the ability to manufacture sufficient cells for infusion.

Subjects with TNBC who meet procurement eligibility criteria will have cells collected to manufacture iC9-CAR.B7-H3 T cells. Eligible subjects will receive lymphodepletion with cyclophosphamide and fludarabine.

Interventions

  • Biological iC9-CAR.B7-H3 T Cell Therapy
    iC9-CAR.B7-H3 T cells will then be administered intravenously
  • Drug cyclophosphamide
    cyclophosphamide 300 mg/m2 IV will be given.
  • Drug fludarabine
    fludarabine 30 mg/m2 IV will be given.

Primary outcome measures

  • Toxicity: NCI-CTCAE [Time frame: Up to 4 weeks]
  • Toxicity: Cytokine Release Syndrome (CRS) [Time frame: Up to 8 weeks after infusion of Biological/Vaccine]
  • Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) [Time frame: Up to 4 weeks]
Secondary outcome measures (7)
  • The recommended phase 2 dose (RP2D) NCI-CTCAE v5. [Time frame: Up to 4 weeks]
  • The recommended phase 2 dose (RP2D) CRS Grading [Time frame: Up to 4 weeks]
  • The recommended phase 2 dose (RP2D) [Time frame: Up to 4 weeks]
  • Objective response rate [Time frame: Up to 2 years]
  • Progression Free Survival (PFS) [Time frame: Up to 2 years]
  • Overall Survival (OS) [Time frame: Up to 2 years]
  • Duration of Response (DOR) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:

  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.
  • Age ≥ 18 years at the time of consent.
  • Karnofsky score of > 60% (see APPENDIX VI- Karnofsky Scale))
  • Histologically confirmed TNBC (ER-, PR-, HER2-negative)
  • ER- and PR-negative: defined as < 1% staining by immunohistochemistry (IHC)
  • HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio < 2.0

Exclusion criteria

  • Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
  • Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of North Carolina — Chapel Hill

Identifiers

NCT: NCT06347068 · LCCC2128-ATL · P50CA058223-29A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗