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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06397963
Other study ID # GRIT-CD-CHN-307-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2024
Est. completion date April 18, 2027

Study information

Verified date April 2024
Source Grit Biotechnology
Contact Han Zhengxiang, MD
Phone +86 18052268612
Email cnhzxyq@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date April 18, 2027
Est. primary completion date April 18, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol; - 2. Age 18 to 70 years old; - 3. Patients with advanced solid tumours who have been diagnosed with: failure of standard treatment, no standard treatment, or inaccessible to standard treatment; - 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; - 5. Expected survival time of = 12 weeks; - 6. Good function of vital organs; - 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling; - 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling. Exclusion Criteria: - 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry; - 2.Known mental illness, alcoholism, drug use or substance abuse; - 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion; - 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study; - 5.The investigators determine that other conditions that make the patient not suitable for enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GT307 injection
GT307 injection to treat solid tumours

Locations

Country Name City State
China The Affiliated Hospital Of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Profile Measured by Grade =3 TRAEs To characterize the safety profile of autologous TIL injection(GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade = 3 treatment-emergent adverse events (TEAEs) 3 years
Secondary Objective response rate To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator 3 years
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