CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

NCT07538635 | Not Yet Recruiting Phase 2

• 2 other identifiers: CAR-T+ASCTNo ID
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.

Conditions

High-risk R/R LBCL

Keywords

CAR-T；ASCT；R/R LBCL；high-risk factors

Outcome Measures

Primary Outcomes (1)

• 1-year PFS rate

  1-year progression-free survival rate

  From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months

Secondary Outcomes (5)

• bORR

  The best therapeutic effect within 12 months after CAR-T infusion was the proportion of subjects achieving complete remission (CR) or partial remission (PR).

• DOR

  12 months after CAR-T infusion

• PFS

  From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months

• OS

  From date of CAR-T infusion until the date of first documented date of death from any cause, assessed up to 12 months

• AE and SAE

  All adverse events that occurred from the time of enrollment to 12 months after the CAR-T infusion

Study Arms (1)

CAR-T+ASCT

EXPERIMENTAL

R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7).

Biological: Axicabtagene Ciloleucel

Interventions

Axicabtagene Ciloleucel BIOLOGICAL

R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7). A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

CAR-T+ASCT

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)
• Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
• Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
• Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression
• Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement
• ECOG 0 to 2
• Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy
• Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL/min
• Left ventricular ejection fraction (LVEF) ≥ 40%
• Life expectancy ≥ 3 months

You may not qualify if:

• Patients who have previously received any CD19-targeted therapy
• Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities
• Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases
• History of human immunodeficiency virus (HIV) infection
• Pregnant or lactating patients

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhengjiang, 310022, China

Location

MeSH Terms

Interventions

axicabtagene ciloleucel

Central Study Contacts

Xi Chen

CONTACT

+8617816890591; zjuchenxi@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief director of Lymphoma Department

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)