Injection of immune cells to treat advanced solid tumors

A Single-arm Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injections for the Treatment of Advanced Solid Tumors

This study is testing whether injecting immune cells from patients' own tumors can help people with advanced solid tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, prednisone
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06094426 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and tolerability of injecting autologous tumor-infiltrating lymphocytes in patients with advanced solid tumors. It is a multicenter, single-arm, open-label study that includes a dose-escalation phase followed by a dose-expansion phase. The study aims to assess pharmacokinetics and efficacy of the treatment in patients with unresectable recurrent or metastatic solid tumors. Participants will have at least one resectable lesion for the preparation of the lymphocytes.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable recurrent or metastatic solid tumors who have at least one resectable lesion.

Not a fit: Patients with solid tumors that are resectable or have received prior local therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients with advanced solid tumors.

How similar studies have performed: Other studies using similar immunotherapy approaches have shown promising results, indicating potential for success in this trial.

Eligibility criteria

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:

* 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);

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Yi Zhang, PHD

Conditions Solid Tumor; Adult; GT316