Efficacy and Safety of Chidamide Combined With PD-1 Inhibitor as Maintenance Therapy Following CAR-T Cell Treatment With TP53-Mutated Large B-Cell Lymphoma (LBCL) (CP-LBCL)

November 12, 2026 updated by: Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

A Prospective, Single-Arm, Single-Center Study on the Efficacy and Safety of Chidamide Combined With PD-1 Inhibitor as Maintenance Therapy Following CAR-T Cell Treatment in Patients With TP53-Mutated Large B-Cell Lymphoma (LBCL)

This is a study for patients with a type of blood cancer called large B-cell lymphoma (LBCL) who have a mutation in a gene called TP53. This gene mutation often makes the cancer harder to treat with standard therapies.

CAR T-cell therapy is a treatment that uses a patient's own immune cells to fight cancer. However, some patients relapse (the cancer comes back) after CAR T-cell therapy. This study will test whether taking two drugs - chidamide (a tablet taken by mouth) and a PD-1 inhibitor (given by intravenous infusion) - as maintenance therapy after CAR T-cell therapy can help keep the cancer from coming back.

Participants in this study will receive CAR T-cell therapy, followed by maintenance treatment with chidamide combined with a PD-1 inhibitor. Doctors will closely monitor participants for how well the treatment works and for any side effects. The study will take place at a single hospital, and all participants will receive the same treatment.

The main goal of the study is to find out if this maintenance treatment is effective and safe for patients with TP53-mutant large B-cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

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

  • Name: Aibin Liang, Prof,MD,phD
  • Phone Number: +86-21-66113037
  • Email: zll3032@163.com

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Recruiting
        • Shanghai Tongji Hospital, Tongji 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or pathologically confirmed relapsed/refractory aggressive large B-cell lymphoma;
  2. Documented TP53 mutation confirmed by genetic testing;
  3. Age 18-70 years, inclusive; both sexes eligible;
  4. Patient has elected and is able to complete a CAR T-cell therapy regimen;
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  6. Life expectancy of at least 3 months;
  7. Adequate major organ function (within 7 days prior to initiation of study treatment):

(1) Hepatic function: ALT/AST <3 × the upper limit of normal (ULN), and total bilirubin ≤34.2 μmol/L; (2) Renal function: serum creatinine <220 μmol/L; (3) Pulmonary function: oxygen saturation ≥95% on room air; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;

8. Patient is able to swallow and take oral medication;

9. Patient has adequate peripheral superficial venous access suitable for intravenous infusion;

10. Voluntary participation in the clinical study; full awareness and understanding of the study; written informed consent provided; willingness and ability to comply with and complete all study procedures.

Exclusion Criteria:

  1. Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use contraception;
  2. Concurrent malignancy of another organ system requiring treatment;
  3. Uncontrolled coagulation disorder or active bleeding;
  4. Known human immunodeficiency virus (HIV) infection;
  5. Currently receiving other antineoplastic therapy (for lymphoma or any other type of tumor);
  6. Psychiatric illness, or any other known or suspected inability to fully comply with the study protocol;
  7. Inability to swallow capsules, or any disease significantly affecting gastrointestinal function, such as malabsorption syndrome, prior bariatric (weight-reduction) surgery, inflammatory bowel disease, or partial or complete bowel obstruction;
  8. Any other concurrent and uncontrolled medical condition that, in the investigator's judgment, would affect the patient's participation in the study.

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: Chidamide + PD-1 Inhibitor Maintenance

Participants will receive CAR T-cell therapy as planned by the treating physician. After CAR T-cell infusion, participants will receive maintenance therapy with oral chidamide combined with an intravenous PD-1 inhibitor, continued until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned maintenance duration. Treatment response and adverse events will be monitored regularly.
Drug: chidamide+PD-1 inhibitor

Chidamide is an oral subtype-selective histone deacetylase (HDAC) inhibitor. Participants will take chidamide orally at the dose of 20mg twice week and schedule specified in the protocol, starting after CAR T-cell infusion, and continuing until disease progression, unacceptable toxicity, or completion of the planned maintenance duration.

Sintilimab is a humanized anti-programmed death-1 (PD-1) monoclonal antibody administered by intravenous infusion. Participants will receive it at the dose of 200mg/21days, in combination with oral chidamide, until disease progression, unacceptable toxicity, or completion of the planned maintenance duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of CAR-T cell infusion (Day 0) to date of documented disease progression or death from any cause, assessed every 3 months for up to 24 months]

Progression-Free Survival
From date of CAR-T cell infusion (Day 0) to date of documented disease progression or death from any cause, assessed every 3 months for up to 24 months]
OS
Time Frame: From date of CAR-T cell infusion (Day 0) to date of death from any cause, assessed every 3 months for up to 24 months]

Overall Survival
From date of CAR-T cell infusion (Day 0) to date of death from any cause, assessed every 3 months for up to 24 months]
ORR
Time Frame: From date of CAR-T cell infusion (Day 0) to Day 90 (±14 days), assessed by PET-CT or MRI according to Lugano 2014 criteria

Overall Response Rate
From date of CAR-T cell infusion (Day 0) to Day 90 (±14 days), assessed by PET-CT or MRI according to Lugano 2014 criteria

Collaborators and Investigators

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

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 30, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 12, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 12, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hem-2026-Chidamide

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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