Nüks/Dirençli B Hücreli Kanserlerin Tedavisinde CD19/CD20 Çift Hedefli in Vivo CAR-T Lentiviral Ürünü

Sade dilde özet

Bu çalışma, nüks eden veya tedaviye dirençli B hücreli kanserlerin (B-cell malignancies) tedavisinde CD19/CD20 çift hedefli in vivo CAR-T lentiviral ürününü incelemektedir. Çalışmaya, nüks/dirençli non-Hodgkin lenfoma (NHL) veya kronik lenfositik lösemi (CLL) tanılı, 18 yaş ve üzeri hastalar alınmaktadır. Faz 1 aşamasında yürütülmekte ve halen katılımcı almaktadır.

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Katılımcı alıyor

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Müdahale

CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product

Başlangıç

23.05.2025

Tahmini bitiş

30.06.2029

Ülkeler

China

İlgili genler

Merkezler

• Hefei, China
• Beijing, China
• Shijiazhuang, China
• Zhengzhou, China
• Wuhan, China
• Nanjing, China

Uygunluk kriterleri

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

Inclusion Criteria:

1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
2. Age greater than or equal to 18.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. At least one evaluable tumor lesion.
5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
6. Life expectancy≥ 3 months
7. Clinical laboratory values meet screening visit criteria
8. Adequate organ function;

Exclusion Criteria:

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;
2. Prior treatment with lentiviral vector-based gene therapies;
3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
5. Lactating women;