NCT05475847

Brief Summary

A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 25, 2022

Last Update Submit

July 26, 2022

Conditions

Cervical Cancer

Keywords

Gynecological tumorTumor Infiltrating Lymphocytes

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AE)

    To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion.

    up to 12 months or through study completion

Secondary Outcomes (6)

  • Objective Response Rate (ORR)

    up to 12 months or through study completion

  • Disease Control Rate (DCR)

    up to 12 months or through study completion

  • Duration of Response (DOR)

    up to 12 months or through study completion

  • Time to Response (TTR)

    up to 12 months or through study completion

  • Overall Survival（OS）

    up to 12 months or through study completion

  • +1 more secondary outcomes

Study Arms (1)

C-TIL052A treatment group

EXPERIMENTAL

C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)

Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection

Interventions

Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) InjectionBIOLOGICAL

C-TIL052A injection followed by injection of IL-2

C-TIL052A treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 70 years at screening
  • Voluntary participation and able to sign the informed consent form
  • Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment.
  • Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes
  • At least one measurable target lesion (per RECIST v1.1)
  • ECOG performance status score: 0\~1
  • Expected survival ≥ 3 months
  • Negative serum or urine pregnancy test results for females of child-bearing age at screening

You may not qualify if:

  • Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)
  • Symptomic chronic obstructive pulmonary disease or persistent asthma
  • Uncontrolled cardiovascular diseases
  • History of primary immune deficiency, autoimmune disease or chronic inflammatory disease
  • High-risk subjects with rapid tumor progression as judged by the Investigator(s)
  • Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS
  • History of organ transplantation or allogeneic cell therapy
  • Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Xiaohua Wu, MD, Ph.D

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Jian Zhang, MD, Ph.D

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Wu, MD, Ph.D

CONTACT

021-64175590-82900docwxh@hotmail.com

Jian Zhang, MD, Ph.D

CONTACT

021-64175590-73546Syner2000@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)