Clinical trial NCT05475847: Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
Official title: A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cervical Cancer
Keywords: Gynecological tumor
Tumor Infiltrating Lymphocytes
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai AbelZeta Ltd.
First posted: 2022-07-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: up to 12 months or through study completion
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 12 months or through study completion
measure: Disease Control Rate (DCR)
timeFrame: up to 12 months or through study completion
measure: Duration of Response (DOR)
timeFrame: up to 12 months or through study completion
measure: Time to Response (TTR)
timeFrame: up to 12 months or through study completion
measure: Overall Survival（OS）
timeFrame: up to 12 months or through study completion
measure: Progression Free Survival（PFS）
timeFrame: up to 12 months or through study completion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaohua Wu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jian Zhang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: