The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

June 21, 2018 updated by: Xin Wang
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main purpose:

To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas.

The Secondary purpose:

The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma.

  1. The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents.
  2. Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci.
  3. Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain.
  4. Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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 Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Kailin K Xu, DOCTOR
          • Phone Number: +86 0516 85802398
          • Email: lihmd@163.com
        • Contact:
        • Principal Investigator:
          • Kailin K Xu, DOCTOR

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

10 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.

2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.

5. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.

9.ECOG评分≤2. 10. Patients need to sign informed consent.

Exclusion Criteria:

  1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
  2. Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
  3. The patient is an active hepatitis B or hepatitis C infection.
  4. The patient received genetic product treatment within six months.
  5. The patient participated in a clinical trial within six months.
  6. The patient has a severe autoimmune disease.
  7. The doctor thinks that there are other reasons that can't be accepted.

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: CD20 CAR-T cells
Experimental: CD20 CAR-T cells
Drug: CD20 CAR-T cells
A total of 1 - 20×10^6 CD20 CAR-T cells/kg will be administered by IV infusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study related adverse events [ Time Frame: 4 weeks ]
Time Frame: 4 weeks
Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Activity Endpoint Detection
Time Frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart
The PCR method was used to detect the copy number of the exogenous CAR vector in the blood until the end of the test was negative for both tests.
24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart

Collaborators and Investigators

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

Sponsor

Xin Wang

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)

April 4, 2018

Primary Completion (ANTICIPATED)

April 3, 2019

Study Completion (ANTICIPATED)

April 3, 2020

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (ACTUAL)

July 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHLY1701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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