NCT06517004

An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Detailed description

This is an open-label, single-arm, investigator-initiated study (IIT) to evaluate the safety an JWCAR201 in adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). The study employs a two-stage, Continual Reassessment Method (CRM)-like dose escalation design. In the first stage, each dose cohort will use an accelerated titration approach, escalating to the dose level at which a Dose-Limiting Toxicity (DLT) occurs or the 50 × 10\^6 CAR+ T-cell dose level (whichever is reached first). The second stage will start at observed DLT dose level or the 50\^6 CAR+ T-cell dose level, an model-based CRM method using a single-parameter Logistic model will be used to describe the relationship between the JWCAR201 dose and the probability of observed DLTs. The Maximum Tolerated Dose (MTD) is defined as the highest an estimated DLT probability below the 25% target toxicity level. For each dose level, a prior mean DLT risk (skeleton) will be set based on historical data. After enrolling ≥3 patients perort, the prior DLT risk will be updated based on the available study data, and the DLT risk will be communicated to the Data Safety Monitoring Committee to recommend the next cohort dose. The study plans to start at 25 × 10\^6 CAR+ T cells as the initial dose, with exploration across three dose levels (25 × 10\^6, 50 × 10\^6, 75 × 10\^6 CAR+ T cells), and 15 × 10\^6 CAR+ T cells or lower and 100 × 10\^6 CAR+ T cells or higher as backup doses, aiming to evaluate the safety, tolerability of JWCAR201 in r/r DLBCL and determine the recommended dose for expansion. Additionally, pharmacokinetic and pharmacodynamic characteristics are also study objectives.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	JWCAR201	Autologous CD19/CD20-directed CAR-T cells, single infusion intravenously

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-12-01
• Completion: 2027-08-01
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: China