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TerminatedNCT06094426Updated Apr 29, 2026

Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors

An Early Phase 1 interventional study of GT316 in Solid Tumor, Adult and GT316, sponsored by Grit Biotechnology. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Grit Biotechnology · Early Phase 1, Interventional, and Treatment

Why this study was terminated
The study was terminated from a business perspective.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2023, registered Oct 2023).
Phase
Early Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This trial is a multicenter, single-arm, open design designed to evaluate the safety and tolerability of Autologous Tumor Infiltrating Lymphocyte Injection in the treatment of patients with advanced solid tumors, as well as pharmacokinetic profiling and efficacy. The trial consists of two phases: dose-escalation and dose-expansion.

02

Conditions studied

  • Solid Tumor
  • Adult
  • GT316
03

In context

Lead sponsor

Grit Biotechnology is the lead sponsor of 30 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1.The Patients (or legally authorized representative) 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 informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
  • 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
  • 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion criteria

Exclusion Criteria:

  • 1.Patients with ≥3 untreated CNS metastases at the time of screening (patients were included if they had ≤3 CNS metastases with a maximum diameter of \<1 cm and no peritumor edema on brain imaging (MRI or CT) and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment)
  • 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
  • 3. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
  • 4.Patients with refractory or intractable epilepsy, drug-uncontrolled pleural effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding or contraindications to IL-2;
  • 5. Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same;
  • 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
  • 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    GT316 treatment group

    Biological: GT316

Interventions

  • BiologicalGT316

    Autologous Tumor Infiltrating Lymphocyte Injection

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events per CTCAE 5.0

    To characterize the safety profile of autologous TIL injection in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0

    Time frame: 3 years

07

Study locations

1 site
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06094426
Lead sponsor
Grit Biotechnology
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Feb 26, 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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