CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL

May 13, 2024 updated by: He Huang, Zhejiang University

A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The first affiliated hospital of medical college of zhejiang university
        • Contact:
        • 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. Gender unlimited，18< Age;
  • 2. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma

  • 3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):

    1. CR not achieved after standardized chemotherapy;
    2. CR achieved following the first induction, but CR duration is less than 12 months;
    3. Ineffectively after first or multiple remedial treatments;
    4. 2 or more relapses;
  • 4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
  • 5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;

  • 6. Relapsed or refractory B-NHL (meeting one of the following conditions):

    1. No response or relapse after second-line or above chemotherapy regimens;
    2. Primary drug resistance;
    3. Relapse after auto-HSCT;
  • 7. At least one assessable tumor lesion per Lugano 2014 criteria;
  • 8. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  • 9. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • 10. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  • 11. Estimated survival time ≥ 3 months;
  • 12. ECOG performance status 0 to 2;
  • 13. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

  • 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • 3. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion
  • 4. Patients with HIV infection;
  • 5. Active infection of hepatitis B virus or hepatitis C virus;
  • 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • 7. Other uncontrolled diseases that were not suitable for this trial;
  • 8. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
  • 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of 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: Administration of CD19-BAFF Targeted CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Biological: CD19-BAFF Targeted CAR T-cells
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
Other Names:
  • CD19-BAFF Targeted CAR T-cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Up to 28 years after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Up to 2 years after Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival, EFS
Time Frame: Up to 1 years after CAR-T infusion
The time from first achieving CR/CRi to relapse or death
Up to 1 years after CAR-T infusion
Overall survival, OS
Time Frame: Up to 1 years after CAR-T infusion
The time from CAR-T infusion to death due to any cause
Up to 1 years after CAR-T infusion
Overall response rate ,ORR
Time Frame: Up to 12 weeks after CAR-T infusion
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
Time Frame: Up to 1 years after CAR-T infusion
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Up to 1 years after CAR-T infusion

Collaborators and Investigators

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

Sponsor

Zhejiang University

Collaborators

Shanghai YaKe Biotechnology Ltd.

Investigators

  • Principal Investigator: He Huang, MD, Zhejiang 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 (Estimated)

May 30, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Estimated)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXB2023022

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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