CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies

March 4, 2021 updated by: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

This is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or refractory hematological malignancies in CD19 / CD20 positive B cell lines.

The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen receptor T cell infusion targeting CD19/CD20 in the treatment of relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CD19 and CD20 are two proteins expressed in normal B cells and various B cell-derived hematological malignancies, including non Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (all) and chronic lymphoblastic leukemia (CLL). CD19 and CD20 are restricted to the surface of B cells. They are not expressed in hematopoietic stem cells, nor in other tissue cells. They exist in all stages of B cell development and differentiation. They are not lost from the cell surface until B cells differentiate into plasma cells. Clinical studies have found that CD19 and CD20 are excellent targets for immunotherapy of B-cell malignancies.The purpose of this study was to observe the efficacy and safety of treatment for patients with relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Provincial Hospital
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Only subjects meeting all of the following conditions were included in the study:

  • The subjects who voluntarily participated in the study and signed the written informed consent;
  • The age at the time of signing the informed consent is 3-70 years old, regardless of gender or race;
  • The patients with CD19 / CD20 positive hematological malignancies without other effective treatment options include those who are not suitable for allogeneic stem cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases; Other contraindications, such as total body irradiation (TBI) contraindications (TBI is one of the important treatment measures before allogeneic stem cell transplantation in all patients); Lack of suitable donors;
  • Expected survival > 12 weeks;
  • Relapse after any stem cell transplantation (no matter what previous treatment plan); and;

  • Patients who relapsed after previous allogeneic SCT (myeloablative or non myeloablative) and met all other inclusion criteria:

    1. There was no active GVHD and no immunosuppression was required;
    2. Transplantation lasted more than 4 months;
  • Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;
  • Serum AST and alt ≤ 5 x upper limit of normal value (ULN);
  • It is necessary to have indicators for disease detection or evaluation, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;
  • Cardiac function: left ventricular ejection fraction greater than or equal to 40%;
  • ECoG physical condition (PS) ≤ 2;
  • The pregnant test results of fertile female subjects within 48 hours before the infusion were negative and they were not in lactation period; all fertile female subjects took adequate contraceptive measures before entering the study and within 3 months after stopping the last infusion during the whole study period.

Exclusion criteria:

  • Pregnant or lactating female patients;
  • Participate in another clinical trial within 4 weeks before the study, or intend to participate in another clinical trial during the whole study period;
  • Uncontrolled active infection;
  • The history of human immunodeficiency virus is known;
  • Active hepatitis B or hepatitis C infection;
  • The systemic steroid treatment is needed during cell infusion or cell collection, or there are some diseases that researchers think may need steroid treatment during blood collection or infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone for physiological replacement therapy in patients with adrenocortical insufficiency are also allowed;
  • There are grade 2-4 acute or systemic chronic GVHD;
  • There is GVHD under treatment;
  • Patients with cns3 disease progression or central nervous system parenchymal lesions that may increase central nervous system toxicity; patients with active central nervous system leukemia or lymphoma infiltration;
  • Absolute neutrophil count < 750 / μ L or platelet count < 50000 / μ l caused by non primary diseases;
  • When collecting cells, they received systemic chemotherapy 2 weeks ago or radiotherapy 3 weeks ago;
  • Researchers believe that it is not suitable to participate in this clinical trial due to various reasons.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CD19/CD20 CAR-T cell infusion
CD19/CD20 CAR-T cell infusion on relapsed or refractory hematological malignancies of CD19 / CD20+ B cell line
Drug: CD19/CD20 CAR-T cell infusion
CD19/CD20 CAR-T,Infusion,iv,0.2×10^6-5×10^6γδT /kg,once
Other Names:
  • Targeting CD19、CD20 autologous chimeric antigen receptor T cells#

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR 3
Time Frame: three months after CAR-T cells infusion
3-month objective response rate
three months after CAR-T cells infusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anhui Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xingbing Wang, No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PA-CART-1920-I -001

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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