Actively Recruiting
Evaluation of Safety, Tolerability, and Efficacy of CD30-Targeted LCAR-HL30 Cells in Adults With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
Led by Ruijin Hospital · Updated on 2024-07-10
32
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LCAR-HL30, a chimeric antigen receptor (CAR)-T cell therapy, in adults with relapsed or refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. This open-label, single-arm, exploratory clinical study aims to assess the safety, tolerability, pharmacokinetics, and anti-tumor effects of LCAR-HL30 in these patients. The trial is sponsored by Ruijin Hospital and includes adults aged 18 to 75 years with confirmed CD30-positive lymphoma. Participants will receive a conditioning premedication regimen of cyclophosphamide and fludarabine before the infusion of LCAR-HL30 cells. The study involves sequential stages: screening, pre-treatment with lymphodepleting chemotherapy, treatment with LCAR-HL30 infusion, and follow-up. This phase 1 study focuses on finding the recommended dose and monitoring the therapy’s behavior in the body. During the study, patients will be closely monitored for treatment-emergent adverse events and pharmacokinetics in blood and bone marrow for up to four years after infusion. Researchers will assess response rates, duration of remission, progression-free survival, overall survival, and the presence of antibodies against LCAR-HL30. Participants will undergo laboratory tests and clinical evaluations throughout the follow-up period to evaluate safety and efficacy outcomes.
CONDITIONS
Brief Title
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation in clinical research.
- Age between 18 and 75 years, any sex.
- ECOG performance status 0-1 for dose escalation phase; 0-2 for dose expansion phase.
- Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
- At least one tumor lesion evaluable by Lugano 2014 criteria.
- Expected survival of 3 months or more.
- Clinical laboratory values meet screening criteria.
- Use of effective contraception.
You will not qualify if you...
- Recent antitumor therapy without sufficient washout period.
- Previous CAR-T therapy or allogeneic hematopoietic stem cell transplantation.
- Severe underlying diseases.
- Positive tests for hepatitis B surface antigen, HBV DNA, hepatitis C RNA, or HIV antibodies.
- Other serious medical conditions limiting study participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants receive lymphodepleting chemotherapy as conditioning before the LCAR-HL30 infusion.
Participants receive an infusion of LCAR-HL30 cells, a chimeric antigen receptor T cell therapy targeting CD30.
Duration - Minimum 2 years up to 4 years
Participants are monitored for safety, tolerability, pharmacokinetics, and anti-tumor efficacy for a minimum of 2 years and up to 4 years after infusion.
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
J
Jianqing Mi
W
Wenyan Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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