An Open, Single-armed, Phase I Study to Evaluate the Safety and Efficacy Using Autologous TIL in Patients With Advanced Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a 3+3 dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patients must be ≥18 and ≤75 years of age at the time of consent.

• Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.

• At least one measurable target lesion even after resection, as defined by RECIST1.1.

• Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion.

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patients must have an estimated life expectancy of ≥3 months.

• In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.

• Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:

‣ White Blood Cell (WBC)≥2.5×10\^9/L;

⁃ Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L;

⁃ Absolute Lymphocyte Count(ALC)≥0.7×10\^9/L;

⁃ Platelet≥100×10\^9/L;

⁃ International Normalized Ratio(INR)≤1.5×ULN;

⁃ Activated Partial Thromboplastin Time(APTT)≤1.5×ULN;

⁃ Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min

⁃ Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g;

⁃ Alanine aminotransferase(AST/SGOT) ≤3×ULN;

⁃ Alanine aminotransferase (ALT/SGPT) ≤3×ULN;

⁃ Total Bilirubin(TBIL)≤1.5×ULN;

• Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy.

• Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.

⁃ Patients must have no contraindications for surgery or biopsy.

⁃ Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Mengmeng Tang
clinicaltrials@juncell.com
86-021-69110327
Time Frame
Start Date: 2022-07-30
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Experimental: Cohort 1
dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL
Experimental: Experimental: Cohort 2
participants with advanced cervix tumors using cryopreserved GC101 TIL
Experimental: Experimental: Cohort 3
participants with advanced malignant melanoma using cryopreserved GC101 TIL
Experimental: Experimental: Cohort 4
participants with advanced HNSCC using cryopreserved GC101 TIL
Sponsors
Leads: Shanghai Juncell Therapeutics

This content was sourced from clinicaltrials.gov

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