A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
NCT06494371 · Phase 1 · Shanghai, China
- Condition
- Lymphoma
- Disease stage
- Stage I-IV
- Phase
- Phase 1
- Study type
- BIOLOGICAL
- Intervention
- LCAR-HL30 cells
- Age
- 18 Years to 75 Years
- Gender
- All
- Sponsor
- Ruijin Hospital
- Research institution
- Ruijin Hospital
- Facility
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- Research center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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 receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.
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.
Primary outcomes
Incidence, severity, and type of treatment-emergent adverse events (TEAEs); Pharmacokinetics in peripheral blood; Pharmacokinetics in peripheral blood
Secondary outcomes
Objective Response Rate (ORR) after administration; Time to Response (TTR) after administration; Duration of Remission (DoR) after administration