AzTrials
AzTrials

Lymphoma, Non-HodgkinPhase 2NCT04089215

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

A Phase 2 study testing CD19-targeted Chimeric Antigen Receptor (CAR) T Cells in people with Lymphoma, Non-Hodgkin and Diffuse Large B Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
10 sitesChina
Study dates
11 Jun 2019to 30 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to participate in the study:
  • ≥ 18 years old;
  • Sign on the informed consent;
  • Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
  • Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Show all 11Show fewer
  • Adequate organ function;
  • Adequate vascular access for leukapheresis procedure;
  • Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
  • Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
  • 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.

Who cannot join

  • Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
  • History of another primary malignancy that has not been in remission for at least 2 years;
  • Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
  • Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
  • Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
  • Presence of acute or chronic graft-versus-host disease (GVHD);
Show all 11Show fewer
  • History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
  • Pregnant or nursing women;
  • 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;
  • Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
  • Received CAR T-cell or other genetically-modified T-cell therapy previously.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

  • Institute of Hematology&Hospital of Blood Disease CAMS

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Zhenzhou Universtity

    Zhenzhou, Henan

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Keywords
JWCAR029, B-Cell Malignancies, non-Hodgkin lymphoma, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19-targeted Chimeric Antigen Receptor (CAR) T CellsBiological

    JWCAR029 be administered at dose level: 1 x 10^8 CAR+T cells and 1.5 x 10^8 CAR+T cells

Study groups in NCT04089215
Study groupRoleWhat they receive
JWCAR029 treatmentExperimentalJWCAR029 be administrated in two dose level
Receives: Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) in LBCL subjects in cohort A;

    Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjects；

    Measured: 3 months

  2. Complete response rate (CRR) in FL subjects in cohort B

    Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects

    Measured: 3 months

Secondary outcomes (22)

  1. Complete response rate (CRR) in cohort A of LBCL subjects

    Measured: 3 months

  2. Objective response rate (ORR) in cohort B of FL subjects

    Measured: 3 months

  3. Adverse events (AEs)

    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.

    Measured: up to 24 months after JWCAR029 infusion

  4. Duration of response (DOR)

    Time from first response(PR or CR) to disease progression or death from any cause.

    Measured: up to 24 months after JWCAR029 infusion

  5. Duration of complete remission (DoCR)

    Time from complete response (CR) to disease progression or death from any cause.

    Measured: up to 24 months after JWCAR029 infusion

  6. Duration of partial remission (DoPR)

    Time from partial response (PR) to disease progression or death from any cause.

    Measured: up to 24 months after JWCAR029 infusion

  7. Time to response (TTR)

    Time from JWCAR029 infusion to first documentation of CR or PR

    Measured: up to 24 months after JWCAR029 infusion

  8. Time to complete response (TTCR)

    Time from JWCAR029 infusion to first documentation of CR

    Measured: up to 24 months after JWCAR029 infusion

  9. Pharmacokinetic (PK)- Cmax of JWCAR029

    Maximum observed concentration of JWCAR029 in peripheral blood

    Measured: up to 1 year after JWCAR029 infusion

  10. Pharmacokinetic (PK)- Tmax of JWCAR029

    Time to maximum concentration of JWCAR029 in the peripheral blood

    Measured: up to 1 year after JWCAR029 infusion

  11. Pharmacokinetic (PK)- AUC of JWCAR029

    Area under the concentration vs time curve of JWCAR029

    Measured: up to 1 year after JWCAR029 infusion

  12. Progression-free survival (PFS)

    Measured: 3 to 5 years after JWCAR029 infusion

  13. Overall survival

    Measured: 3 to 5 years after JWCAR029 infusion

  14. Quality of Life C30 questionnaire (EORTC-QLQ-C30)

    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

    Measured: up to 2 year after JWCAR029 infusion

  15. European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L)

    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)

    Measured: up to 2 year after JWCAR029 infusion

  16. ICU and non-ICU hospitalization days

    Measured: up to 2 year after JWCAR029 infusion

  17. ICU and non-ICU hospitalization reasons

    Measured: up to 2 year after JWCAR029 infusion

  18. Anti-therapeutic JWCAR029 antibody

    Measured: up to 2 year after JWCAR029 infusion

  19. Changes of T cell counts, subgroups and serum cytokines

    Measured: up to 2 year after JWCAR029 infusion

  20. CD19 expression in tumor biopsy samples

    Measured: up to 2 year after JWCAR029 infusion

  21. Changes of inflammation biomarkers-CRP

    Measured: up to 1 year after JWCAR029 infusion

  22. Changes of inflammation biomarkers-serum ferritin

    Measured: up to 1 year after JWCAR029 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start11 Jun 2019
  3. Primary completion10 Sep 2021
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089215
Sponsor's protocol ID
JWCAR029-002
Status last verified
Nov 2023
First submitted
10 Sep 2019
Last updated
24 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Zhang P, Yang S, Zhou Z, Zheng H, Song Y, Zhu J. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 2021 Feb;10(3):999-1011. doi: 10.1002/cam4.3686. Epub 2020 Dec 31.

    PubMed 33382529

  • Song Y, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Xia Z, Zhang Y, Zhou Z, Zhu J. Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. Br J Haematol. 2025 Oct;207(4):1476-1483. doi: 10.1111/bjh.20122. Epub 2025 Sep 1.

    PubMed 40888120

  • Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study. Cytotherapy. 2023 May;25(5):521-529. doi: 10.1016/j.jcyt.2022.10.011. Epub 2023 Feb 24.

    PubMed 36842849

  • Ying Z, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Preliminary efficacy and safety of Relmacabtagene autoleucel (Carteyva) in adults with relapsed/refractory follicular lymphoma in China: A phase I/II clinical trial. Am J Hematol. 2022 Dec;97(12):E436-E438. doi: 10.1002/ajh.26711. Epub 2022 Sep 14. No abstract available.

    PubMed 36053875

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD19-targeted Chimeric Antigen Receptor (CAR) T Cells in people with Lymphoma, Non-Hodgkin and Diffuse Large B Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) in LBCL subjects in cohort A; (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089215, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in