Araştırmacı Tarafından Başlatılan TBI-1201 Faz 1 Çalışması

Sade dilde özet

Bu çalışmada, MAGE-A4 proteinini taşıyan solid (katı) tümörü olan hastalara, MAGE-A4'e özgü T hücre reseptörü (TCR) geni aktarılmış T lenfositler (TBI-1201) verilmektedir. Hücre naklinden önce hastalara siklofosfamid ve/veya fludarabin ile hazırlık tedavisi uygulanmaktadır. Faz 1 (Phase 1) çalışmaya, doku ya da hücre incelemesiyle tanısı doğrulanmış, ameliyatla çıkarılamayan, standart tedaviye dirençli, metastatik veya nükseden tümörü olan, HLA-A*24:02 pozitif ve tümöründe MAGE-A4 ifadesi saptanan hastalar alınmıştır.

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Mie University

Müdahale

TBI-1201 (MAGE-A4-specific TCR gene transduced T lymphocytes), Cyclophosphamide (Endoxan), Fludarabine (Fludara)

Başlangıç

01.04.2014

Tahmini bitiş

01.03.2021

Ülkeler

Japan

İlgili genler

Merkezler

• Tsu, Japan

Uygunluk kriterleri

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

Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumors
2. Solid tumor, which is unresectable , refractory to standard therapy (chemotherapy, radiotherapy, etc) , metastatic or recurrent
3. HLA-A\*24:02 positive
4. MAGE-A4-expression by PCR or immunohistochemistry
5. ECOG Performance Status, 0 or 1
6. Age \>20 years on consent
7. No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
8. Life expectancy \>= 16 weeks after consent
9. No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:

   * WBC \> 2,500/μL
   * Hemoglobin \> 8.0g/dL
   * Platelets \> 75,000/μL
   * T. bilirubin \< 1.5 x ULN
   * AST(GOT)、ALT(GPT) \< 3.0 x ULN
   * Creatinine \< 1.5 x ULN
10. Ability to understand the study contents and to give a written consent at his/her free will.

Exclusion Criteria:

1. The following serious complications are excluded from the study;

   * Unstable angina, cardiac infarction, or heart failure
   * Uncontrolled diabetes or hypertension
   * Active infection
   * Obvious interstitial pneumonia or lung fibrosis by chest X-ray
   * Active autoimmune disease requiring steroids or immunosuppressive therapy
2. Serious hypersensitivity
3. Tumor cell invasion into CNS
4. Active multiple cancer
5. Positive for HBs antigen/antibody, HBc antibody, or HCV antibody, and virus DNA observed in serum, except for HBs antibody positive case who had vaccine injection before.
6. Positive for antibodies against HIV or HTLV-1
7. Left Ventricular Ejection Fraction (LVEF): =\< 50％
8. Percutaneous Oxygen saturation: \< 94％
9. History of hypersensitivity reactions to bovine or murine derived substances.
10. History of hypersensitivity reaction to drugs used in this study
11. Psychological disorder or drug dependency which may have impact on the consent.
12. Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study
13. Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.