Status:
RECRUITING
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen recept...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
- Severe underlying diseases;
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06494371
Start Date
July 1 2024
End Date
August 1 2028
Last Update
July 10 2024
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China