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Non Hodgkin LymphomaPhase 1NCT03355859

Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

A Phase 1 study testing JWCAR029 in people with Non Hodgkin Lymphoma, run by Zhao Weili at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
JWCAR029
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
5 Jan 2018to Mar 2022
Phase
Phase 1
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 be enrolled in this study:
  • Age ≥ 18 years at the time of consent
  • Signed written informed consent obtained prior to any study procedures
  • Relapsed or refractory B-cell NHL.
  • PET-positive disease BY Lugano classification
  • Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
  • Adequate vascular access for leukapheresis procedure
  • Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
  • Subjects must agree to use appropriate contraception.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from participation in this study:
  • Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
  • History of another primary malignancy that has not been in remission for at least 2 years.
  • Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
  • Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
  • Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
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  • Presence of acute or chronic graft-versus-host disease (GVHD)
  • History of cardiovascular disease
  • History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  • Pregnant or nursing women.
  • Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Phase 1, Open-Label Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Adult Subjects With Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.

Being tested
JWCAR029
Keywords
Non Hodgkin Lymphoma, CD19-targeted chimeric antigen receptor, JWCAR029
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • JWCAR029Biological

    Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.

Study groups in NCT03355859
Study groupRoleWhat they receive
JWCAR029ExperimentalThe safety and efficacy of JWCAR029 will be evaluated in a standard 3+3 dose escalation approach. 4 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8 CAR+ T cells.
Receives: Biological: JWCAR029

What is being measured

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

  1. Treatment-related adverse events (AEs)

    Physiological parameter

    Measured: 2 years

  2. Dose-limiting toxicities of JWCAR029

    Physiological parameter

    Measured: 28 days after JWCAR029 infusion

  3. Objective response rate (ORR)

    Lugano criteria

    Measured: 2 years

Secondary outcomes (8)

  1. Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow

    Flow cytometry and qPCR

    Measured: 1 year after JWCAR029 infusion

  2. Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow

    Flow cytometry and qPCR

    Measured: 1 year after JWCAR029 infusion

  3. Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow

    Flow cytometry and qPCR

    Measured: 1 year after JWCAR029 infusion

  4. Complete response (CR) rate

    Lugano criteria

    Measured: 2 years

  5. Duration of response

    Lugano criteria

    Measured: 2 years

  6. Progression-free survival (PFS) and PFS ratio

    Lugano criteria

    Measured: 2 years

  7. Overall survival

    Physiological parameter

    Measured: 2 years

  8. Health-related quality of life (HRQoL)

    Questionnaire

    Measured: 2 years

Timeline

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

  1. First posted28 Nov 2017
  2. Study start5 Jan 2018
  3. Primary completionDec 2019 (estimated)
  4. Study completionMar 2022 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03355859
Sponsor's protocol ID
JWCAR029-001
Status last verified
Jul 2019
First submitted
22 Nov 2017
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PubMed 34515338

  • Yan ZX, Li L, Wang W, OuYang BS, Cheng S, Wang L, Wu W, Xu PP, Muftuoglu M, Hao M, Yang S, Zhang MC, Zheng Z, Li J, Zhao WL. Clinical Efficacy and Tumor Microenvironment Influence in a Dose-Escalation Study of Anti-CD19 Chimeric Antigen Receptor T Cells in Refractory B-Cell Non-Hodgkin's Lymphoma. Clin Cancer Res. 2019 Dec 1;25(23):6995-7003. doi: 10.1158/1078-0432.CCR-19-0101. Epub 2019 Aug 23.

    PubMed 31444250

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JWCAR029 in people with Non Hodgkin Lymphoma, run by Zhao Weili at 1 site 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Treatment-related adverse events (AEs) (time frame: 2 years). The study lists 3 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 NCT03355859, which also lists 2 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 12 Jul 2019.

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