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Diffuse Large B Cell LymphomaPhase 1NCT04812691

CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma

A Phase 1 study testing JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) in people with Diffuse Large B Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesChina
Study dates
10 Jul 2020to 25 Apr 2023
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

  • ≥ 18 years old;
  • Sign on the informed consent;
  • Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;
  • 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;
  • Adequate organ function;
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  • 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

  • Subjects who have received second-line treatment or above
  • CD19 negative
  • 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;
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  • Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
  • Presence of acute or chronic graft-versus-host disease (GVHD);
  • 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

2 sites in 1 country.

China2 sites

  • Zhejiang university school of medicine first affiliated hospital

    Hangzhou, Zhejiang

  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study

This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China

Read the detailed description

This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment.

One dose level of 1.0 x 10^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion.

Being tested
JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)
Keywords
Primary refractory
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)Biological

    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 1 x 10^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.

Study groups in NCT04812691
Study groupRoleWhat they receive
JWCAR029ExperimentalThe safety and efficacy of JWCAR029 will be evaluated in 1 x 10^8 CAR+T cells dose level
Receives: Biological: JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)

What is being measured

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

  1. Types, frequency, and severity of adverse events and laboratory anomalies

    Physiological parameter

    Measured: 2 years

Secondary outcomes (20)

  1. Complete response rate (CRR) in primary refractory DLBCL subjects

    Investigator evaluated CRR in 1 month

    Measured: 1 month

  2. Objective response rate (ORR) in primary refractory DLBCL subjects

    Investigator evaluated ORR in 1 month

    Measured: 1 month

  3. Best objective response rate (BORR)

    The best response from the onset of treatment to the onset of disease progression/recurrence or to the onset of another anticancer treatment

    Measured: 2 years

  4. Investigator evaluated CRR

    Complete response rate (CRR)

    Measured: 3 months

  5. Investigator evaluated ORR (ORR=CR+PR)

    Complete response (CR) + partial response（PR）

    Measured: 3 months

  6. 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

  7. 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

  8. Time to response (TTR)

    Time from JWCAR029 infusion to first documentation of CR or PR

    Measured: up to 24 months after JWCAR029 infusion

  9. Time to complete response (TTCR)

    Time from JWCAR029 infusion to first documentation of CR

    Measured: up to 24 months after JWCAR029 infusion

  10. Pharmacokinetic (PK)- Cmax of JWCAR029

    Maximum observed concentration of JWCAR029 in peripheral blood

    Measured: up to 1 year after JWCAR029 infusion

  11. Pharmacokinetic (PK)- Tmax of JWCAR029

    Time to maximum concentration of JWCAR029 in the peripheral blood

    Measured: up to 1 year after JWCAR029 infusion

  12. Pharmacokinetic (PK)- AUC of JWCAR029

    Area under the concentration vs time curve of JWCAR029

    Measured: up to 1 year after JWCAR029 infusion

  13. Progression-free survival (PFS)

    Progression-free survival

    Measured: up to 2 year after JWCAR029 infusion

  14. Overall survival (OS)

    Overall survival

    Measured: up to 2 year after JWCAR029 infusion

  15. Changes of CRP and serum ferritin

    Changes of inflammation biomarkers-CRP and serum ferritin

    Measured: 1 year after JWCAR029 infusion

  16. Anti-therapeutic JWCAR029 antibody

    The level of anti-therapeutic JWCAR029 antibody after JWCAR029 infusion

    Measured: up to 2 year after JWCAR029 infusion

  17. The concentration of Car-T cell

    The concentration of Car-T cells

    Measured: up to 2 year after JWCAR029 infusion

  18. The proportion of Car-T cell subgroups

    The proportion of Car-T cell subgroups after infusion

    Measured: up to 2 year after JWCAR029 infusion

  19. The concentration of CD19 in tumor biopsy samples

    The concentration of CD19 in tumor biopsy samples

    Measured: up to 2 year after JWCAR029 infusion

  20. The change of serum cytokines concentration

    The change of serum cytokines concentration after JWCAR029 infusion

    Measured: up to 2 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 posted24 Mar 2021
  2. Study start10 Jul 2020
  3. Primary completion30 Jun 2021
  4. Study completion25 Apr 2023

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812691
Sponsor's protocol ID
JWCAR029-003
Status last verified
Nov 2023
First submitted
18 Jan 2021
Last updated
22 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) in people with Diffuse Large B Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 2 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 22 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 2 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Types, frequency, and severity of adverse events and laboratory anomalies (time frame: 2 years). 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 NCT04812691.

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 22 Nov 2023.

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