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Safety and EfficacyPhase 1NCT04677452

Dose Exploration Study OF JWCAR129, BCMA-Targeted CART for RRMM

A Phase 1 study testing JWCAR129 in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Safety and Efficacy
What is being tested?
JWCAR129
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Dec 2020to Dec 2024
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 and above.
  • Signed the Informed Consent Form.
  • Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects must be refractory to the last anti-myeloma treatment regimen prior to entering the study.
  • Autologous hematopoietic stem cell transplantation.
  • A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination. Subjects must have undergone at least 2 consecutive cycles of treatment for each regimen unless progressive disease was the best response to the regimen.
  • Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy.
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  • Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible; the reason for not receiving treatment must be clearly documented in the case report form.
  • Subjects must have measurable disease.
  • Subject must be willing to provide fresh bone marrow biopsy samples during Screening (and prior to study treatment, if required).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function

Who cannot join

  • Subjects with known active or history of CNS involvement by malignancy
  • Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasmaproliferative disorder, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
  • History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.
  • Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
  • Prior CAR T-cell or other genetically-modified T-cell therapy
  • Prior treatment with a BCMA-targeted agent
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  • 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
  • Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JWCAR129 infusion.
  • History of any of the following cardiovascular conditions within 6 months of initial screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease
  • History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used in this study
  • Allogeneic hematopoietic stem cell transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • First Affiliated Hospital, Soochow University

    Suzhou, Jiangsu, 215000

    Fu chengcheng, Phd, 13962191404, fuzhengzheng@suda.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-Label Phase 1 Dose Exploration Study of JWCAR129, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma

This is an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma.

Being tested
JWCAR129

What participants receive

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

  • JWCAR129Biological

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR129. During JWCAR129 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JWCAR129 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JWCAR129 administered intravenously (IV).

Study groups in NCT04677452
Study groupRoleWhat they receive
JWCAR129ExperimentalSubjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single dose of JWCAR129
Receives: Biological: JWCAR129

What is being measured

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

  1. Incidence of dose-limiting toxicities (DLTs)

    Proportion of subjects with adverse events meeting DLT criteria

    Measured: 28 days

  2. Incidence and severity of adverse events

    Proportion of subjects with adverse events overall and by severity grade

    Measured: 2 years

  3. Incidence and severity of clinically significant laboratory abnormalities

    Proportion of subjects with clinically significant laboratory abnormalities overall and by severity grade

    Measured: 2 years

Secondary outcomes (6)

  1. Cmax

    Maximum concentration (Cmax) of JWCAR129 in the blood

    Measured: 2 years

  2. Tmax

    Time to maximum concentration (Tmax) of JWCAR129 in the blood

    Measured: 2 years

  3. AUC

    Area under the concentration vs time curve (AUC) of JWCAR129 in the blood

    Measured: 2 years

  4. Duration of persistence

    Duration of persistence of JWCAR129 CAR T cells in the blood

    Measured: 2 years

  5. Overall response rate

    Proportion of subjects with a partial response (PR) or better by IMWG criteria

    Measured: 2 years

  6. CR rate

    Proportion of subjects with a CR by IMWG criteria

    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 posted21 Dec 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionDec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04677452
Sponsor's protocol ID
JWCAR129
Status last verified
Dec 2020
First submitted
16 Dec 2020
Last updated
21 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JWCAR129 in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow University 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 21 Dec 2020. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) (time frame: 28 days). 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 NCT04677452.

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 21 Dec 2020.

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