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Sequential CD19/CD22 CAR-T Cell Therapy Following ASCT

NCT07236151 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2023-09-21
Completion
2025-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236151 on ClinicalTrials.gov