Treatment for relapsed Hodgkin's and Anaplastic Large Cell Lymphoma using LCAR-HL30
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
PHASE1 · Ruijin Hospital · NCT06494371
This study is testing a new treatment called LCAR-HL30 to see if it can help adults with relapsed Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma feel better.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06494371 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and effectiveness of LCAR-HL30, a chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Participants will undergo a series of stages including screening, pre-treatment with lymphodepleting chemotherapy, and treatment with LCAR-HL30 infusion. The study aims to assess the pharmacokinetics and anti-tumor efficacy of this innovative therapy. It is designed as a single-arm, open-label exploratory study, meaning all participants will receive the treatment without a control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma who have positive CD30 expression.
Not a fit: Patients who have previously received CAR-T therapy or allogeneic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Jianqing Mi
- Email: jianqingmi@shsmu.edu.cn
- Phone: 13524488296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma