Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517004
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
An Open-label Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relapsedrefractory diffuse large B-cell lymphoma rr 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 50 106 CAR T-cell dose level whichever is reached first The second stage will start at observed DLT dose level or the 506 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 25 106 CAR T cells as the initial dose with exploration across three dose levels 25 106 50 106 75 106 CAR T cells and 15 106 CAR T cells or lower and 100 106 CAR T cells or higher as backup doses aiming to evaluate the safety tolerability of JWCAR201 in rr DLBCL and determine the recommended dose for expansion Additionally pharmacokinetic and pharmacodynamic characteristics are also study objectives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None