A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma

Launched by RUIJIN HOSPITAL · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LCAR-HL30 for adults with certain types of blood cancer, specifically relapsed or refractory Hodgkin's lymphoma and Anaplastic large cell lymphoma. The trial is open to adults aged 18 to 75 who have been diagnosed with these conditions and have tumors that can be measured. Participants will receive LCAR-HL30 and help researchers understand how well it works and its safety.

To join the trial, participants need to be in good enough health and have a life expectancy of at least three months. They should not have had certain previous treatments that could interfere with the study. The trial is currently recruiting participants, and anyone who joins can expect regular monitoring and support throughout the process. This study aims to provide valuable information that could help improve treatment options for people with these types of cancers in the future.

Gender

ALL

Eligibility criteria

• 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.