Using CD30 CAR-T therapy for treating relapsed lymphoma

Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

This study is testing a new treatment using modified T cells to see if it can help people with relapsed lymphoma that has the CD30 marker.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 15 Years to 80 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: CAR-T, CAR T
• Locations: 1 site (Taiyuan, Shangxi)
• Trial ID: NCT06850285 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, open-label study that evaluates the safety and efficacy of CD30 CAR-T therapy in patients with relapsed or refractory CD30-positive lymphoma. The study aims to recruit 15 participants and will assess the metabolism of CD30 CAR-T cells in vivo, as well as the correlation between CAR T cell dose and clinical efficacy. Participants will receive chimeric antigen receptor gene modified T cells specifically targeting CD30-positive malignancies.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 to 80 with CD30-positive lymphoma who are not suitable for other treatments like autologous stem cell transplantation.

Not a fit: Patients with central nervous system involvement or those who have not expressed CD30 in their malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory CD30-positive lymphoma.

How similar studies have performed: Other studies using CAR-T therapies have shown promising results, indicating potential success for this approach in treating similar conditions.

Eligibility criteria

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.

Where this trial is running

Taiyuan, Shangxi

• Shanxi Bethune Hospital — Taiyuan, Shangxi, China (Recruiting)

Study contacts

• Principal investigator: jia wei — Shanxi Bethune Hospital
• Study coordinator: jia wei

Conditions Lymphoma, B-Cell; CD30 CAR-T; lymphoma