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RecruitingPhase 1NCT06494371

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

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

Sponsor

Ruijin Hospital

Enrollment

32 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hodgkin's LymphomaAnaplastic Large Cell Lymphoma

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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 Criteria5

  • 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.

Interventions

BIOLOGICALLCAR-HL30 cells

Prior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine

Locations(1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT06494371

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