A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma

May 31, 2026 updated by: The First Affiliated Hospital of Soochow University

A Study Evaluated Efficacy and Safety of CD19/22 Chimeric Antigen Receptor T Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R B-NHL.

Study Type

Interventional

Enrollment (Actual)

18

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 Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • The First Affiliated Hospital of Soochow University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):

    A.The lesion shrinkage <50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen

  2. Age ≥ 18 years
  3. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points

  4. The main organ functions need to meet the following conditions:

    A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 > 90%

  5. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
  6. Expected survival exceeds 3 months
  7. Written informed consent could be acquired

Exclusion Criteria:

  1. Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
  2. Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection
  3. Active hepatitis B or hepatitis C infection
  4. HIV infection
  5. Severe acute or chronic graft-versus-host disease (GVHD)
  6. Participated in any other drug research clinical trials within 30 days before enrollment
  7. Prior CART cells therapy within 3 months before enrollment
  8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
  9. Have contraindications to the PD-1 inhibitors
  10. Uncontrolled other tumor
  11. Women in pregnancy,lactation or planning to become pregnant
  12. The researcher considers inappropriate to participate in this research

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: CD19/22 CART cells combined with PD-1 inhibitors
Patients will receive PD-1 inhibitor on the first day after CART cell infusion
Biological: CD19/22 CART
CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10*107 CART cells per kilogram of body weight.
Drug: Tislelizumab
Patients will receive Tislelizumab 200mg/dose every 3 weeks.
Other Names:
  • PD-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 1 year
Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.
1 year
Progression-free survival(PFS)
Time Frame: 1 year
PFS will be assessed from the first CART cell infusion to progression,death or last follow-up.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete relapse rate(CR)
Time Frame: 1 year
Number of patients who achieved complete response after treatment by CD19/22 CART combined with PD-1 inhibitor.
1 year
Duration of overall response (DOR)
Time Frame: 1 year
Duration of overall response will be assessed from the first CAR-T cell infusion to progression,death or last follow-up.
1 year
Overall survival(OS)
Time Frame: 1 year
OS will be assessed from the first CART cell infusion to death or last follow-up.
1 year
Incidence of treatment-related adverse events
Time Frame: 1 year
The incidence rate of adverse events from the first day of preconditioning chemotherapy to 1 year after CART cells infusion
1 year

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Investigators

  • Study Chair: Depei Wu, M.D., The First Affiliated Hospital of Soochow University

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)

August 1, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPD-1 in lymphoma

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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