A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
- Conditions
- Hodgkin's LymphomaAnaplastic Large Cell Lymphoma
- Interventions
- Biological: LCAR-HL30 cells
- Registration Number
- NCT06494371
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Subjects voluntarily participate in clinical research.
- Aged 18 to 75 years, either sex.
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
- Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
- Expected survival ≥3 months.
- Clinical laboratory values in the screening period meet criteria.
- Effective contraception.
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
- Severe underlying diseases;
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chimeric antigen receptor T cells LCAR-HL30 cells LCAR-HL30 cells Each subject will receive LCAR-HL30 cells.
- Primary Outcome Measures
Name Time Method Pharmacokinetics in bone marrow Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) CAR transgene levels in bone marrow after LCAR-HL30 infusion.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Pharmacokinetics in peripheral blood Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) CAR transgene levels in peripheral blood after LCAR-HL30 infusion.
Recommended Phase 2 Dose (RP2D) regimen finding Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) after administration Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LCAR-HL30 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014).
Time to Response (TTR) after administration Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) TTR is defined as the time from the date of first infusion of LCAR-HL30 to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Overall Survival (OS) after administration Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) OS is defined as the time from the date of first infusion of LCAR-HL30 to death of the subject.
Duration of Remission (DoR) after administration Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Progression-free Survival (PFS) after administration Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) PFS is defined as the time from the date of first infusion of the LCAR-HL30 to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Incidence of anti-LCAR-HL30 antibody Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1) The incidence of anti-LCAR-HL30 antibody in patients who received LCAR-HL30 infusion.
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China