NCT06494371 A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
| NCT ID | NCT06494371 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ruijin Hospital |
| Condition | Hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-07 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2024-07 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06494371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hodgkin's Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06494371 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06494371 currently recruiting?
Yes, NCT06494371 is actively recruiting participants. Contact the research team at jianqingmi@shsmu.edu.cn for enrollment information.
Where is the NCT06494371 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06494371 clinical trial?
NCT06494371 is sponsored by Ruijin Hospital. The trial plans to enroll 32 participants.