A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LCAR-HL30 cells
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Ruijin Hospital
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator
Source ClinicalTrials.gov