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Multi-4SCAR-T Therapy Targeting Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.

Age: ≥ 18 years and ≤ 75 years.

2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.

Side effects of chemotherapy have subsided.

Disqualifiers

Airway obstruction caused by tumor.

History of epilepsy or other central nervous system diseases.

Patients who require systemic corticosteroid or other immunosuppressive therapy.

History of prolonged or serious heart disease during QT.

Trial design

Design model

Single group

Treatments tested in this trial

  • 4SCAR T cells

    Biological/Vaccine

    Infusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Multiple 4SCAR T cells to treat breast cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with adverse events.

Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0

Time frame
3 year

Secondary outcomes

1

Anti-tumor effects

Disease status is defined by the image scan to get the outcomes such as Complete response/remission (CR), Very good partial response/remission (VGPR), etc.

Time frame
3 year
2

The expansion and persistence of CAR-T cells

The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.

Time frame
3 months
3

Survival time of the patients

The survival time of the patients treated with the multi-4SCAR T cells, including progression free survival (PFS) and overall survival (OS) will be evaluated.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: