A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma

NCT06494371 | Recruiting Phase 1

• 1 other identifier: LB2203-0001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma; Anaplastic Large Cell Lymphoma

Keywords

Hodgkin's Lymphoma; Anaplastic Large Cell Lymphoma

Outcome Measures

Primary Outcomes (6)

• Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

  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.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR transgene levels in peripheral blood after LCAR-HL30 infusion.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Pharmacokinetics in bone marrow

  CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Pharmacokinetics in bone marrow

  CAR transgene levels in bone marrow after LCAR-HL30 infusion.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Recommended Phase 2 Dose (RP2D) regimen finding

  RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

Secondary Outcomes (6)

• Objective Response Rate (ORR) after administration

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Time to Response (TTR) after administration

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Duration of Remission (DoR) after administration

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Progression-free Survival (PFS) after administration

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

• Overall Survival (OS) after administration

  Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

Study Arms (1)

Chimeric antigen receptor T cells LCAR-HL30 cells

EXPERIMENTAL

Each subject will receive LCAR-HL30 cells.

Biological: LCAR-HL30 cells

Interventions

LCAR-HL30 cells BIOLOGICAL

Prior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine

Chimeric antigen receptor T cells LCAR-HL30 cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Central Study Contacts

Jianqing Mi

CONTACT

13524488296; jianqingmi@shsmu.edu.cn

Wenyan Yu

CONTACT

13564230293; ywy01778@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)