Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT07236151
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sequential CD19/CD22 CAR-T Cell Therapy Following ASCT
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
A Clinical Study of Sequential CD19/CD22 CAR-T Cell Therapy Following Autologous Stem Cell Transplantation in Relapsed/Refractory Large B-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if sequential CD19/CD22 CAR-T cell therapy following autologous stem cell transplantation (ASCT) works to treat relapsed or refractory large B-cell lymphoma (LBCL) in adults. It will also learn about the safety of this treatment combination. The main questions it aims to answer are:
Does ASCT followed by sequential CD19/CD22 CAR-T therapy improve complete response rates in participants with relapsed/refractory LBCL? What medical problems do participants have when receiving this treatment combination? Researchers will evaluate the safety and efficacy of ASCT followed by sequential CD19/CD22 CAR-T therapy to determine if this treatment approach works to improve outcomes for patients with relapsed/refractory LBCL.
Participants will:
Undergo two separate apheresis procedures for stem cell collection and CAR-T cell manufacturing.
Receive conditioning chemotherapy followed by autologous stem cell infusion on day 0.
Receive sequential CD19 and CD22 CAR-T cell infusions over 3 days within one week post-transplant.Visit the clinic regularly for checkups and tests to monitor their response to treatment and any potential side effects.
Keep a record of their symptoms and any adverse events experienced during the treatment period.
Does ASCT followed by sequential CD19/CD22 CAR-T therapy improve complete response rates in participants with relapsed/refractory LBCL? What medical problems do participants have when receiving this treatment combination? Researchers will evaluate the safety and efficacy of ASCT followed by sequential CD19/CD22 CAR-T therapy to determine if this treatment approach works to improve outcomes for patients with relapsed/refractory LBCL.
Participants will:
Undergo two separate apheresis procedures for stem cell collection and CAR-T cell manufacturing.
Receive conditioning chemotherapy followed by autologous stem cell infusion on day 0.
Receive sequential CD19 and CD22 CAR-T cell infusions over 3 days within one week post-transplant.Visit the clinic regularly for checkups and tests to monitor their response to treatment and any potential side effects.
Keep a record of their symptoms and any adverse events experienced during the treatment period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: