Tümörle İlişkili Antijene Özgü İmmün Efektör Hücrelerine Dayalı İmmünoterapi

Sade dilde özet

Bu çalışma, tümörle ilişkili antijenler taşıyan kanser hastalarında, genetik olarak düzenlenmiş (mühendislik ürünü) bağışıklık hücrelerine dayalı bir immünoterapiyi incelemektedir. Çalışmaya, tümör örneklerinde GD2, mezotelin gibi antijenlerden biri veya birkaçı pozitif olan, ileri evre (FIGO Evre III-IV) hastalar katılmaktadır. Çalışma Faz 1/Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Katılımcı alıyor

Sponsor

Shenzhen Geno-Immune Medical Institute

Müdahale

Engineered Immune Cells

Başlangıç

01.07.2025

Tahmini bitiş

31.12.2029

Ülkeler

China

İlgili genler

Merkezler

• Shenzhen, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* 1\. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4.

  3\. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.

  7\. Not pregnant, and on appropriate birth control if of childbearing potential.

  8\. Adequate bone marrow reserve with
  * absolute neutrophil count (ANC) ≥ 1000/mm3.
  * Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with
  * Serum creatinine ≤ 2 x upper limit of normal (ULN).
  * Serum bilirubin ≤ 2 x ULN.
  * aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
  * Alkaline phosphatase ≤ 5 x ULN.
  * Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.

Exclusion Criteria:

* 1\. The results of immune staining of the patient's tumor-associated antigens are all negative.

  2\. Previous experience of other cell therapy. 3. Participation in any other cell therapy protocols within one year. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.

  5\. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).

  6\. Pregnant or lactating females. 7. Unable to comply with the trial related requirement. 8. Inadequate bone marrow function:

  • Absolute neutrophil count \< 1.0 x 10e9/L.• Platelet count \< 100 x 10e9/L.• Hb \< 9 g/dL.

Inadequate liver and renal function:

* Serum (total) bilirubin \> 1.5 x ULN.
* AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases).
* Alkaline phosphatase \> 2.5 x ULN (or \> 5 x ULN in case of liver metastases or \> 10 x ULN in case of bone metastases).
* Serum creatinine \>2.0 mg/dl (\> 177 μmol/L).
* Urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr.

  9\. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.