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

NCT ID: NCT06494371

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2028-08-31

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 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.

Conditions

Hodgkin's Lymphoma; Anaplastic Large Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chimeric antigen receptor T cells LCAR-HL30 cells

Each subject will receive LCAR-HL30 cells.

Group Type: EXPERIMENTAL

LCAR-HL30 cells

Intervention Type: BIOLOGICAL

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

Interventions

LCAR-HL30 cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianqing Mi

Role: CONTACT

jianqingmi@shsmu.edu.cn

13524488296

Wenyan Yu

Role: CONTACT

ywy01778@rjh.com.cn

13564230293

Facility Contacts

Wenyan Yu

Role: primary

Other Identifiers

LB2203-0001

Identifier Type: -

Identifier Source: org_study_id