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

Last updated: July 4, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Leukemia

Lymphoma

Treatment

LCAR-HL30 cells

Clinical Study ID

NCT06494371
LB2203-0001
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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). ECOGscore 0-2 (Dose expansion period).

  4. Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma withpositive 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

Exclusion Criteria:

  1. Prior antitumor therapy with insufficient washout period.

  2. Previous treatment with CAR-T therapy, allogeneic hematopoietic stem celltransplantation.

  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 immunodeficiencyvirus antibody (HIV-Ab) positive.

  5. Presence of other serious pre-existing medical conditions that may limit patientparticipation in the study. Any condition that, in the investigator's judgment, willmake the subject unsuitable for participation in this study.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: LCAR-HL30 cells
Phase: 1
Study Start date:
July 01, 2024
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

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