Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours

Solid Tumor, Adult Clinical Trial

Official title:

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397963
• Other study ID #: GRIT-CD-CHN-307-002
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

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