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Trial Title:
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
NCT ID:
NCT06494371
Condition:
Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Conditions: Keywords:
Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LCAR-HL30 cells
Description:
Prior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication
regimen consisting of cyclophosphamide and fludarabine
Arm group label:
Chimeric antigen receptor T cells LCAR-HL30 cells
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyan Yu
Investigator:
Last name:
Jianqing Mi
Email:
Principal Investigator
Start date:
July 2024
Completion date:
August 2028
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Nanjing Legend Biotech Co.
Agency class:
Industry
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06494371
