Treatment for relapsed Hodgkin's and Anaplastic Large Cell Lymphoma using LCAR-HL30

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 study evaluates the safety and effectiveness of LCAR-HL30, a chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Participants will undergo a series of stages including screening, pre-treatment with lymphodepleting chemotherapy, and treatment with LCAR-HL30 infusion. The study aims to assess the pharmacokinetics and anti-tumor efficacy of this innovative therapy. It is designed as a single-arm, open-label exploratory study, meaning all participants will receive the treatment without a control group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects voluntarily participate in clinical research.
2. Aged 18 to 75 years, either sex.
3. Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
4. Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
6. Expected survival ≥3 months.
7. Clinical laboratory values in the screening period meet criteria.
8. Effective contraception.

Exclusion Criteria:

1. Prior antitumor therapy with insufficient washout period.
2. Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
3. Severe underlying diseases;
4. Hepatitis B virus surface antigen (HbsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive.
5. Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jianqing Mi
• Email: jianqingmi@shsmu.edu.cn
• Phone: 13524488296

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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.