Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy

March 11, 2020 updated by: Timmune Biotech Inc.

Adoptive Immunotherapy for Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell

This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma，blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri-functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR-NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.

Study Type

Interventional

Enrollment (Anticipated)

12

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 Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570100
        • Recruiting
        • Hainan Cancer Hospital
        • Contact:
      • Haikou, Hainan, China, 570100
      • Haikou, Hainan, China, 570100
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
  2. All subjects must be able to comply with all the scheduled procedures in the study;
  3. Refractory or relapsed malignant Non-Hodgkin lymphoma, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed in ≤12 months of ASCT;
  4. At least one measurable lesion per revised IWG Response Criteria;
  5. Aged <70 years;
  6. Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2;
  7. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
  8. All other treatment induced adverse events must have been resolved to ≤grade 1;
  9. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

  1. Presence of fungal, bacterial, viral, or other infection that is hardly to control（defined by investigator）;
  2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
  3. Lactating women or women of childbearing age who plan to conceive during the time period;
  4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
  5. Known history of infection with HIV;
  6. Subjects need systematic usage of corticosteroid;
  7. Subjects need systematic usage of immunosuppressive drug;
  8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
  9. Other reasons the investigator consider the patient may not be suitable for 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: CD19-TriCAR-T/SILK
CD19-TriCAR-T/SILK cells will be administered intravenously
Biological: CD19-TriCAR-T/SILK
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03）
Time Frame: 24 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
Time Frame: 24 months
Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
24 months
Partial response rate [PR] （Partial response rate per the revised International Working Group (IWG) Response Criteria）
Time Frame: 24 months
Partial response rate per the revised International Working Group (IWG) Response Criteria
24 months
Duration of Response （The time from response to relapse or progression）
Time Frame: 24 months
The time from response to relapse or progression
24 months
Progression Free Survival （The time from the first day of treatment to the date on which disease progresses）
Time Frame: 24 months
The time from the first day of treatment to the date on which disease progresses
24 months
Overall Survival （The number of patient alive, with or without signs of cancer）
Time Frame: 24 months
The number of patient alive, with or without signs of cancer
24 months

Collaborators and Investigators

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

Sponsor

Timmune Biotech Inc.

Investigators

  • Principal Investigator: Yao Hongxia, Hainan General Hospital

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)

January 5, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-127

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

product manufactured in and exported from the U.S.

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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