Health TrialsbyHealthPanel

Engineered Immune Effectors Against Cervical Cancer

ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age10-80
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written, informed consent obtained prior to any study-specific procedures.

Age older than 10 years.

Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.

Expected survival ≥ 12 weeks.

Disqualifiers

Patients with

cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;

cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.

Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).

Trial design

Design model

Single group

Treatments tested in this trial

  • CC-EIEs

    Biological/Vaccine

    2 to 4 infusions, once a week, for 1x10\^5\~1x10\^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CC-EIEsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Physiological parameter (measuring cytokine response, fever, symptoms)

Time frame
6 months

Secondary outcomes

1

Functional analyses of CC-EIEs in vitro

The specificity of CC-EIEs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT).

Time frame
4 weeks
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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