Health TrialsbyHealthPanel

Intervention of CAR-T Against Cervical Cancer

ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age: ≥ 18 years and ≤ 70 years.

4 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

  • Cervical cancer-specific CAR-T cells

    Biological/Vaccine

    1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Cervical cancer-specific CAR-T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Physiological parameter (measuring cytokine response)

Time frame
3 months

Secondary outcomes

1

Persistence and proliferation of CART cells in patients

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
2

Anti-tumor effects

Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time frame
1 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
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