- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417750
A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors (MIZAR-001)
An Open, Single-armed, Phase I Study to Evaluate the Safety and Efficacy Using Autologous TIL in Patients With Advanced Malignant Solid Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Mengmeng Tang
- Phone Number: 86-021-69110327
- Email: clinicaltrials@juncell.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100039
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Jianming Xu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection).
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients with symptomatic and/or untreated brain metastases (of any size and any number).
- Patients who are on chronic systemic steroid therapy for any reason.
- Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis.
- Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure.
- Uncontrolled arterial hypertension(SBP≥160mmHg and/or DBP≥100mmHg)or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent.
- Patients who have a left ventricular ejection fraction (LVEF) < 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4.
- Female patients who are pregnant or breastfeeding.
- Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Cohort 1
dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL
|
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL).
After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
|
Experimental: Experimental: Cohort 2
participants with advanced cervix tumors using cryopreserved GC101 TIL
|
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL).
After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
|
Experimental: Experimental: Cohort 3
participants with advanced malignant melanoma using cryopreserved GC101 TIL
|
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL).
After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
|
Experimental: Experimental: Cohort 4
participants with advanced HNSCC using cryopreserved GC101 TIL
|
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL).
After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal Tolerance Dose
Time Frame: Up to Day 28
|
Up to Day 28
|
Dose Limiting Toxicity
Time Frame: Up to Day 28
|
Up to Day 28
|
Adverse Events
Time Frame: Maximum 360 days
|
Maximum 360 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Assessment for Duration of Response
Time Frame: Every 6 weeks for 12 months
|
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
|
Every 6 weeks for 12 months
|
Disease Assessment for Disease Control Rate
Time Frame: Every 6 weeks for 12 months
|
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
|
Every 6 weeks for 12 months
|
Disease Assessment for Progression-Free Survival
Time Frame: Every 6 weeks for 12 months
|
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
|
Every 6 weeks for 12 months
|
Disease Assessment for Objective Response Rate
Time Frame: Every 6 weeks for 12 months
|
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
|
Every 6 weeks for 12 months
|
Quality of Life Assessment
Time Frame: Every 6 weeks for 12 months
|
Evaluate with EORTC QLQ-C30
|
Every 6 weeks for 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GC101 TIL-ST-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumor
-
Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
-
Impact Therapeutics, Inc.RecruitingSolid Tumor | Advanced Solid TumorChina, Taiwan, United States, Australia
-
BeiGeneRecruitingSolid Tumor | Advanced Solid TumorUnited States, New Zealand, Australia, China
-
Pyxis Oncology, IncRecruiting
-
Neurogene Inc.Merck Sharp & Dohme LLCActive, not recruitingSolid Tumor | Advanced Solid TumorUnited States, Australia, Canada
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompletedSolid Tumor | Advanced Solid TumorSpain, United States, Netherlands, United Kingdom
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesChina
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesUnited States
-
Jazz PharmaceuticalsMerck Sharp & Dohme LLCRecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
PharmaEngineNot yet recruitingAdvanced Solid Tumor | Metastatic Solid Tumor
Clinical Trials on TIL therapy
-
Sizhen WangShanghai Biomed-union Biotechnology Co., Ltd.RecruitingAdvanced Pancreatic CancerChina
-
Huashan HospitalShanghai Cell Therapy Research InstituteActive, not recruitingGlioblastoma MultiformeChina
-
Grit BiotechnologyRecruiting
-
H. Lee Moffitt Cancer Center and Research InstituteUnited States Department of DefenseRecruitingUrothelial Carcinoma | Non-Invasive Bladder Urothelial CarcinomaUnited States
-
AgonOx, Inc.Providence St Joseph Health; Phio Pharmaceuticals Corp.RecruitingMelanoma | Gynecologic Cancer | Colorectal Cancer | Lung Cancer | HNSCC | Urogenital CancerUnited States
-
Quanli GaoNot yet recruiting
-
Coombe Women and Infants University HospitalCompletedAspiration; Gastric Contents, AnesthesiaIreland
-
Nurix Therapeutics, Inc.Active, not recruitingCervical Cancer | Endometrial Cancer | Platinum-resistant Ovarian CancerUnited States
-
Hebei Senlang Biotechnology Inc., Ltd.RecruitingGlioblastoma Multiforme, AdultChina
-
Ain Shams UniversityRecruiting