NCT07236151

Sequential CD19/CD22 CAR-T Cell Therapy Following ASCT

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Large B-cell Lymphoma
• CAR T Cell Therapy
• Auto Stem Cell Transplant

Interventions

Type	Name	Description
OTHER	Apheresis and Bridging Therapy	Patients undergo two separate apheresis procedures: * Mobilization and collection of autologous hematopoietic stem cells (HSCs) . * Collection of peripheral blood mononuclear cells (PBMCs) for the manufacture of CD19 and CD22 CAR-T cell products. Bridging therapy may be administered at the investigator's discretion between apheresis and the conditioning regimen.
OTHER	Conditioning and Stem Cell Transplantation	Patients undergo a myeloablative conditioning regimen, followed by the infusion of autologous hematopoietic stem cells on Day 0.
OTHER	CAR-T Cell Administration	Fractionated infusions of CD19-directed and CD22-directed CAR-T cells are completed within one week after HSC infusion.

Timeline

• Start date: 2020-02-24
• Primary completion: 2023-09-21
• Completion: 2025-04-30
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: China