Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

September 25, 2020 updated by: Hebei Senlang Biotechnology Inc., Ltd.
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma

The Secondary research objectives:

To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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
      • Yanda, China
        • Recruiting
        • He bei Yan da Lu dao pei Hospital
        • Contact:
          • Peihua Lu
    • Yizhuang
      • Beijing, Yizhuang, China, 100000
        • Recruiting
        • BeiJing Ludaopei Hospital

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

3 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
  2. The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
  3. There should be at least one measurable tumor focus according to the RECIST version 1.1;
  4. ECOG Scores: 0~2;
  5. The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
  6. Estimated survival time was longer than 3 months;
  7. main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation >92%；
  8. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

  1. Serious cardiac insufficiency；
  2. Has a history of severe pulmonary function damaging;
  3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  4. Merging the metabolic diseases (except diabetes);
  5. Merging severe autoimmune diseases or immunodeficiency disease;
  6. Patients with active hepatitis B or hepatitis C virus infection;
  7. Patients with HIV infection or syphilis infection;
  8. Has a history of serious allergies on Biological products (including antibiotics);
  9. Participated in any other clinical drug trial for the last six months;
  10. Being pregnant and lactating or having pregnancy within 12 months;
  11. With other uncontrolled diseases and considered not suitable to participate by the researchers;
  12. Any situations that the researchers believe will increase the risks for the subject or affect the results of 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SL1904B CAR-T
Patients will be treated with CD19 CAR-T cells
Biological: CD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Incidence and severity of adverse events
Time Frame: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)
Time Frame: 3 months post CAR-T cells infusion
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B
3 months post CAR-T cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy:duration of response (DOR)
Time Frame: 24 months post CAR-T cells infusion
duration of response (DOR)
24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
Time Frame: 24 months post CAR-T cells infusion
progression-free survival (PFS) time
24 months post CAR-T cells infusion
CAR-T proliferation
Time Frame: 3 months post CAR-T cells infusion
the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method
3 months post CAR-T cells infusion
Cytokine release
Time Frame: First month post CAR-T cells infusion
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
First month post CAR-T cells infusion

Collaborators and Investigators

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

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Hebei Yanda Ludaopei Hospital
Beijing Lu Daopei Hospital

Investigators

  • Principal Investigator: Peihua Lu, PhD&MD, Beijing Lu Daopei 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)

June 30, 2020

Primary Completion (ANTICIPATED)

August 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1904B for NHL

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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