Using CD30 CAR-T therapy for treating relapsed lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanxi Bethune Hospital
  Taiyuan, Shangxi, China Recruiting

Study contacts

• Principal investigator: jia wei — Shanxi Bethune Hospital
• Study coordinator: jia wei
• Email: iawei@tjh.tjmu.edu.cn
• Phone: 13986102084

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.