Yeni Tanı Almış Ph+ B-ALL İçin Ardışık CD19 ve CD22 CAR-T Tedavisi

Sade dilde özet

Bu çalışma, yeni tanı almış Ph pozitif B hücreli akut lenfoblastik lösemi (Ph+ B-cell acute lymphoblastic leukemia) olan hastalarda CD19 ve CD22'yi hedefleyen ardışık CAR-T hücre tedavisini (bir tür bağışıklık hücresi tedavisi) değerlendirmiştir. Çalışmaya, 18 yaş ve üzeri, Ph kromozomu ve BCR/ABL1 füzyon geni pozitif, lösemi hücreleri CD19 ve CD22 pozitif olan hastalar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Zhejiang University

Müdahale

CAR-T cells targeting CD19 and CD22

Başlangıç

05.03.2021

Tahmini bitiş

31.08.2024

Ülkeler

China

İlgili genler

Merkezler

• Hangzhou, China

Uygunluk kriterleri

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

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
3. Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
4. Leukemia cells were CD19 and CD22 positive;
5. Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
6. Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
7. Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
8. Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
9. The prognosis for survival is more than 3 months;
10. ECOG score 0-2;
11. Subjects volunteered to participate in this trial and signed an informed consent form.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:

1. Those with a history of epilepsy or other central nervous system disorders;
2. Those with a history of prolonged QT period or severe cardiac disease;
3. Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
4. Those with uncontrolled active infection;
5. Active hepatitis B or hepatitis C virus infection;
6. Those who have previously used any gene therapy product;
7. Those with insufficient amplification (\<5-fold) in response to CD3/CD28 co-stimulatory signals;
8. Creatinine \> 2.5 mg/dl or ALT / AST \> 3 times the upper limit of the normal range or bilirubin \> 2.0 mg/dl;
9. Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
10. HIV-infected persons;
11. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.