An Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CD30-Targeted LCAR-HL30 Cells in Patients With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Subjects voluntarily participate in clinical research.
• Aged 18 to 75 years, either sex.
• Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
• Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
• At least one evaluable tumor lesion according to Lugano 2014 criteria.
• Expected survival ≥3 months.
• Clinical laboratory values in the screening period meet criteria.
• Effective contraception.
Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Jianqing Mi
jianqingmi@shsmu.edu.cn
13524488296
Backup
Wenyan Yu
ywy01778@rjh.com.cn
13564230293
Time Frame
Start Date: 2024-07
Estimated Completion Date: 2028-08
Participants
Target number of participants: 32
Treatments
Experimental: Chimeric antigen receptor T cells LCAR-HL30 cells
Each subject will receive LCAR-HL30 cells.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital
Collaborators: Nanjing Legend Biotech Co.