CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma

January 17, 2021 updated by: Shanghai Ming Ju Biotechnology Co., Ltd.

A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma

This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.

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

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with R/R Non-Hodgkins Lymphoma in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect the patient reported quality of life changes and immune response after JWCAR029 treatment.

There will be two cohorts of cohort A and cohort B. Large B cell lymphoma (LBCL) patients will be enrolled in cohort A and follicular lymphoma patients will be enrolled in cohort B. Two dose levels of 1.0 x 10^8 CAR+ T cells and 1.5 x 10^8 CAR+ T cells are adopted in this study in both cohorts, subjects will be randomly assigned into the two dose levels with a 1:1 ratio. All sujects will be followed for 2 years following JWCAR029 infusion.

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.
82

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.
  • Phase 2

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Cancer hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong General Hospital
    • Henan
      • Zhenzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhenzhou Universtity
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai East Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Institute of Hematology&Hospital of Blood Disease CAMS
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer 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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must meet all of the following criteria to participate in the study:

    1. ≥ 18 years old;
    2. Sign on the informed consent;
    3. Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
    4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
    6. Adequate organ function;
    7. Adequate vascular access for leukapheresis procedure;
    8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
    9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
    10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.

Exclusion Criteria:

  1. Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
  2. History of another primary malignancy that has not been in remission for at least 2 years;
  3. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
  4. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
  5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
  6. Presence of acute or chronic graft-versus-host disease (GVHD);
  7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
  8. Pregnant or nursing women;
  9. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
  10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
  11. Received CAR T-cell or other genetically-modified T-cell therapy previously.

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

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: JWCAR029 treatment
JWCAR029 be administrated in two dose level
Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 be administered at dose level: 1 x 10^8 CAR+T cells and 1.5 x 10^8 CAR+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
Objective response rate (ORR) in LBCL subjects in cohort A;
Time Frame: 3 months
Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjects；
3 months
Complete response rate (CRR) in FL subjects in cohort B
Time Frame: 3 months
Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to response (TTR)
Time Frame: up to 24 months after JWCAR029 infusion
Time from JWCAR029 infusion to first documentation of CR or PR
up to 24 months after JWCAR029 infusion
Time to complete response (TTCR)
Time Frame: up to 24 months after JWCAR029 infusion
Time from JWCAR029 infusion to first documentation of CR
up to 24 months after JWCAR029 infusion
Pharmacokinetic (PK)- Cmax of JWCAR029
Time Frame: up to 1 year after JWCAR029 infusion
Maximum observed concentration of JWCAR029 in peripheral blood
up to 1 year after JWCAR029 infusion
Pharmacokinetic (PK)- Tmax of JWCAR029
Time Frame: up to 1 year after JWCAR029 infusion
Time to maximum concentration of JWCAR029 in the peripheral blood
up to 1 year after JWCAR029 infusion
Pharmacokinetic (PK)- AUC of JWCAR029
Time Frame: up to 1 year after JWCAR029 infusion
Area under the concentration vs time curve of JWCAR029
up to 1 year after JWCAR029 infusion
Complete response rate (CRR) in cohort A of LBCL subjects
Time Frame: 3 months
3 months
Objective response rate (ORR) in cohort B of FL subjects
Time Frame: 3 months
3 months
Adverse events (AEs)
Time Frame: up to 24 months after JWCAR029 infusion
Number of participants with adverse events, type of adverse events, severity of adverse events, and number of participants with laboratory abnormalities, type of laboratory abnormalities and severity of laboratory abnormalities.
up to 24 months after JWCAR029 infusion
Duration of response (DOR)
Time Frame: up to 24 months after JWCAR029 infusion
Time from first response(PR or CR) to disease progression or death from any cause.
up to 24 months after JWCAR029 infusion
Duration of complete remission (DoCR)
Time Frame: up to 24 months after JWCAR029 infusion
Time from complete response (CR) to disease progression or death from any cause.
up to 24 months after JWCAR029 infusion
Duration of partial remission (DoPR)
Time Frame: up to 24 months after JWCAR029 infusion
Time from partial response (PR) to disease progression or death from any cause.
up to 24 months after JWCAR029 infusion
Progression-free survival (PFS)
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
Overall survival
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
Quality of Life C30 questionnaire (EORTC-QLQ-C30)
Time Frame: up to 2 year after JWCAR029 infusion
EORTC-QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale
up to 2 year after JWCAR029 infusion
European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L)
Time Frame: up to 2 year after JWCAR029 infusion
The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems)
up to 2 year after JWCAR029 infusion
ICU and non-ICU hospitalization days
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
ICU and non-ICU hospitalization reasons
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
Anti-therapeutic JWCAR029 antibody
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
Changes of T cell counts, subgroups and serum cytokines
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
CD19 expression in tumor biopsy samples
Time Frame: up to 2 year after JWCAR029 infusion
up to 2 year after JWCAR029 infusion
Changes of inflammation biomarkers-CRP
Time Frame: up to 1 year after JWCAR029 infusion
up to 1 year after JWCAR029 infusion
Changes of inflammation biomarkers-serum ferritin
Time Frame: up to 1 year after JWCAR029 infusion
up to 1 year after JWCAR029 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.
Shanghai Ming Ju Biotechnology Co., Ltd.

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)

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.
June 11, 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.
December 31, 2022

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.
September 30, 2024

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).
September 10, 2019

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.
September 11, 2019

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.
September 13, 2019

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.
January 22, 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.
January 17, 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.
January 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.
  • JWCAR029-002

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

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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