CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

January 3, 2026 updated by: Zhao Weili, Ruijin Hospital

A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, single-arm, open-label, prospective clinical trial to evaluate the efficacy and safety of CD19 CAR-T infusion following high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) in relapsed or refractory B-cell Non-Hodgkin's Lymphoma patients with high-risk prognostic factors (extranodal involvement/bulky mass ≥5 cm in diameter/TP53 alterations). CD19 CAR-T will be infused on day +3 (±1d) with a fixed dose of 100X10^6. The study will assess the safety and efficacy of this combinational therapy, including the investigators assessed the best complete response rate (BCR) in 3 months (primary endpoint), objective response rates, survivals, incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities of the subjects.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Li Wang
  • Phone Number: +862164370045

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types

    • diffuse large B-cell lymphoma
    • high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
    • transformed lymphoma
    • primary mediastinal large B-cell lymphoma
    • follicular lymphoma (FL)

  2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)

    • Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
    • Stable disease (SD) as best response after at least 4 cycles of first-line therapy
    • Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)
    • PR as best response after at least 2 cycles of second-line therapy
    • Disease relapse ≤12 months after the completion of first-line immunochemotherapy
    • Relapsed or refractory disease after ≥2 lines of chemotherapy
  3. Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen

  6. Adequate renal and hepatic function defined as:

    • Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
    • Total bilirubin ≤1.5 mg/dL(<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)
    • Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
  7. Cardiac ejection fraction ≥ 40%
  8. Baseline oxygen saturation > 95% on room air
  9. Life expectancy ≥3 months

Exclusion Criteria:

  1. History of autologous or allogeneic stem cell transplantation
  2. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.
  3. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
  4. History of HIV infection
  5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19
  6. Pregnant or lactating patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T following ASCT
Participants will receive high-dose chemotherapy followed by stem-cell infusion, and a fixed dose of CAR-T cells will be infused.
Other: autologous stem-cell transplantation
high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT)
Drug: Relmacabtagene autoleucel (relma-cel)
relma-cel (CD19 CAR-T cell)infusion on day 3(±1d) after ASCT with a fixed dose of 100X10^6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Complete Response (CR) Rate in 3 months
Time Frame: 3months post CAR-T infusion
Best Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
3months post CAR-T infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR) in 3months
Time Frame: 3months post CAR-T infusion
ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators.
3months post CAR-T infusion
Duration of Response (DOR)
Time Frame: 2 years post CAR-T infusion
DOR is defined only for participants who experience an objective response after CAR-T infusion and is the time from the first objective response to disease progression or death from any cause
2 years post CAR-T infusion
Progression-Free Survival (PFS)
Time Frame: 2 years post CAR-T infusion
PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.
2 years post CAR-T infusion
Overall Survival (OS)
Time Frame: 2 years post CAR-T infusion
OS is defined as the time from CAR-T infusion to the date of death from any cause.
2 years post CAR-T infusion
Adverse Events rate as assessed by CTCAE version 5.0
Time Frame: 2 years post CAR-T infusion
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
2 years post CAR-T infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCT-CART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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