CD30 Pozitif Nüksetmiş/Dirençli Lenfoma Tedavisinde CD30 CAR-T

Sade dilde özet

Bu prospektif, açık etiketli (open-label), doz artırımlı (dose-escalation) klinik çalışma, nüksetmiş/dirençli (relapsed/refractory) CD30 pozitif lenfoma tedavisinde CD30 hedefli kimerik antijen reseptörlü T hücre (chimeric antigen receptor T-cell, CAR-T) tedavisinin etkinliğini ve güvenliğini değerlendiriyor. Çalışmaya 15 katılımcı alınması planlanmaktadır. Katılımcıların 15–80 yaş arasında olması, immünohistokimya ile %10'un üzerinde CD30 ifadesi gösteren bir lenfoma tanısı ve ölçülebilir en az bir lezyonu bulunması, ayrıca otolog kök hücre naklinin uygun olmaması veya nakil sonrası nüks yaşanmış olması gerekmektedir.

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

Deney bilgileri

Faz

Faz dışı

Durum

Katılımcı alıyor

Sponsor

Shanxi Bethune Hospital

Müdahale

chimeric antigen receptor gene modified T cells (CAR-T)

Başlangıç

05.09.2025

Tahmini bitiş

01.06.2028

Ülkeler

China

İlgili genler

Merkezler

• Taiyuan, China

Uygunluk kriterleri

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

Inclusion Criteria:

* Age≥15 years and ≤80years，female and male；
* CD30+ lymphocyte malignancies;
* CD30 expression \>10% by immunohistochemistry；
* At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
* Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
* Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
* The estimated survival time ≥3 months;
* ECOG performance status 0-2，KPS\>60%;
* Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\<34 μmol/L；creatinine clearance rate\>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；
* ALC ≥0.5×109/L，PLT\>30×109/L，Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation;
* MRI showed no central involvement of lymphoma;
* Patients with fertility must be willing to be able to use reliable contraceptive measures ;
* The subject or legal guardian can understand and voluntarily sign the written informed consent.

Exclusion Criteria:

* Lymphoma-associated hemophagic cell syndrome;
* Pregnant or lactating women, and women who have a pregnancy plan within six months;
* Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ/Ⅱ and anti-TP positive（Hepatitis B DNA test is negative except）;
* Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;
* Received Anti-CD30 Ab therapy within 4 weeks before enrollment;
* Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments;
* Active uncontrolled bleeding or a known bleeding diathesis;
* Autologous hematopoietic stem cell transplantation was performed within 6 weeks;
* Uncontrollable active bacterial or fungal infection；
* Known allergy to the study drug and its components;
* Suffer from active autoimmune diseases that require systemic treatment ;
* Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
* Participated in other clinical studies within 1 months prior to this study;
* History of allogeneic hematopoietic stem cell transplantation;
* patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.