Sequential CD19/CD22 CAR-T Cell Therapy Following ASCT

NCT07236151 | Completed Phase 2

• 1 other identifier: ASCT+CD19/22 CART
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Best Complete Response Rate

  Best Complete Response Rate (CRR), defined as the proportion of patients achieving a best response of complete response according to the Lugano 2014 criteria.

  From the date of CAR-T cell infusion until the end of the study, with an average follow-up period of approximately 2 years.

Secondary Outcomes (4)

• Overall survival

  From the date of CAR-T cell infusion until the date of death or last follow-up, assessed up to 5 years.

• Event-free survival

  From the date of CAR-T cell infusion to the date of first event (disease progression, relapse, or death) or last follow-up, assessed up to 5 years.

• Adverse event

  Within 30 days after CAR-T cell infusion

• Best Overall Response Rate

  From the date of CAR-T cell infusion until the end of the study, with an average follow-up period of approximately 2 years.

Study Arms (1)

ASCT+ CD19/CD22 CAR-T

EXPERIMENTAL

Other: Apheresis and Bridging Therapy; Other: Conditioning and Stem Cell Transplantation; Other: CAR-T Cell Administration

Interventions

Apheresis and Bridging Therapy OTHER

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.

Also known as: 1

ASCT+ CD19/CD22 CAR-T

Conditioning and Stem Cell Transplantation OTHER

Patients undergo a myeloablative conditioning regimen, followed by the infusion of autologous hematopoietic stem cells on Day 0.

Also known as: 2

ASCT+ CD19/CD22 CAR-T

CAR-T Cell Administration OTHER

Fractionated infusions of CD19-directed and CD22-directed CAR-T cells are completed within one week after HSC infusion.

Also known as: 3

ASCT+ CD19/CD22 CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy.
• \*\[Note: LBCL includes: diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); diffuse large B-cell lymphoma transformed from follicular lymphoma (FL-DLBCL); grade 3b follicular lymphoma (FL); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma with rearrangements of MYC and BCL-2 and/or BCL-6 (double-hit/triple-hit lymphoma, DHL/THL)\].\*
• Age Restriction: Individuals must be 18 to 70 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Presence of at least one measurable target lesion. \*\[Note: A target lesion is defined as ≥1 lesion with a longest diameter (LD) \>1.5 cm and a longest perpendicular diameter (LPD) ≥1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\]\*
• Adequate organ function, defined as:
• Left ventricular ejection fraction (LVEF) ≥50% by echocardiography;
• Creatinine clearance ≥30 mL/min;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN).
• Adequate hematopoietic function, defined as:
• Platelet count ≥45 ×10⁹/L;
• Hemoglobin ≥8.0 g/dL;
• Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L.
• Life expectancy ≥3 months.
• For women of childbearing potential, a negative pregnancy test is required. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter.

You may not qualify if:

• Prior allogeneic hematopoietic stem cell transplantation or CAR-T cell therapy.
• Use of immunosuppressive agents or systemic corticosteroids (equivalent to \>10 mg prednisone daily) within 2 weeks prior to leukapheresis, or requirement for continued use after enrollment.
• Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (anti-HCV positive with detectable HCV RNA) infection at screening.
• Uncontrolled active infection requiring intravenous antimicrobial therapy.
• History of other malignancies within 2 years prior to enrollment (except adequately treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ).
• Significant comorbidities that may compromise study participation or patient safety, including:
• Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, unstable arrhythmias, or angina)
• Severe pulmonary dysfunction (FEV1 or DLCO ≤50% predicted, or requiring supplemental oxygen)
• HIV infection (positive serology with detectable viral load).
• Pregnancy, lactation, or unwillingness to use effective contraception.
• Any condition that in the investigator's judgment would preclude safe participation.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

Blood Component Removal; Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Therapeutics; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 19, 2025
• Study Start: February 24, 2020
• Primary Completion: September 21, 2023
• Study Completion: April 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)