POMES SyndromePhase 1NCT03879382

Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R POMES

A Phase 1 study testing anti-CD19/BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with POMES Syndrome and Relapsed and Refractory POMES Syndrome, run by Hrain Biotechnology Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: POMES Syndrome, Relapsed and Refractory POMES Syndrome
What is being tested?: anti-CD19/BCMA CAR-T cells, Fludarabine and Cyclophosphamide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteChina
Study dates: 27 Feb 2019to 30 May 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

Expected survival > 12 weeks;
Diagnosis of POMES Syndrome;
The criteria for relapsed and refractory POMES Syndrome: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including Alkylating agent and other protein inhibitors (eg: Bortezomib), and have disease progression in the past 60 days;
At least 90 days after stem cell transplantation;
Creatinine≤2.0 mg/dl;
Bilirubin≤2.0 mg/dl;

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The ALT/AST value is lower than 2.5-fold of normal value;
Accessible to intravenous injection, and no white blood cell collection contraindications;
Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom;
5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion;
Able to understand and sign the Informed Consent Document.

Who cannot join

• In the first 5 years before screening, there are malignant tumors other than POMES Syndrome, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery，and catheter carcinoma in situ after radical surgery;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency Viral (HIV) antibody positive; Positive syphilis test;
Any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease requiring medication;
Any other diseases could affect the outcome of this trial;
Any affairs could affect the safety of the subjects or outcome of this trial;
Pregnant or lactating women, or planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;

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Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
Received CAR-T treatment or other gene therapies before enrollment;
Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
Subject suffering disease affects the understanding of informed consent or comply with study protocol;
The investigators consider other conditions unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003

Other trials in China

About this study

Official title: A Phase I Clinical Trial of Human CD19/BCMA Bispecific CAR-T Cell Therapy for Subjects With Relapsed and Refractory POMES Syndrome.

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.

Read the detailed description

Primary Objectives

To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with relapsed and refractory POMES Syndrome.

Secondary Objectives

To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with POMES Syndrome.
To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Conditions: POMES Syndrome, Relapsed and Refractory POMES Syndrome
Being tested: anti-CD19/BCMA CAR-T cells, Fludarabine, Cyclophosphamide
Keywords: CD19/BCMA, Bispecific CAR-T Cell, POMES Syndrome, Relapsed and Refractory
Medical subject headings: Recurrence

What participants receive

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

anti-CD19/BCMA CAR-T cellsBiological
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
FludarabineDrug
30mg/m2/d
CyclophosphamideDrug
300mg/m2/d

Study groups in NCT03879382
Study group	Role	What they receive
anti-CD19/BCMA CAR-T cells	Experimental	Administration with anti-CD19/BCMA CAR-T cells in the relapsed and refractory POMES Syndrome patients Receives: Biological: anti-CD19/BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Measured: 6 months

Secondary outcomes (2)

Overall complete remission rate defined by the standard response criteria for POMES Syndrome
Overall complete remission rate defined by the standard response criteria for POMES Syndrome
Measured: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Measured: 6 months

Timeline

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

27 Feb 201930 May 2022

First posted18 Mar 2019
Study start27 Feb 2019
Primary completion30 Aug 2020
Study completion30 May 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for POMES SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT03879382
Sponsor's protocol ID: HRain-POMES01
Status last verified: Aug 2021
First submitted: 15 Mar 2019
Last updated: 6 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial of Human CD19/BCMA Bispecific CAR-T Cell Therapy for Subjects With Relapsed and Refractory POMES Syndrome.
ClinicalTrials.gov ID: NCT03879382
Acronym / sponsor ID: HRain-POMES01
Conditions: POMES Syndrome, Relapsed and Refractory POMES Syndrome
Keywords: CD19/BCMA, Bispecific CAR-T Cell, POMES Syndrome, Relapsed and Refractory
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Hrain Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Shanghai Changzheng Hospital
Study start: 27 Feb 2019 (actual)
Primary completion: 30 Aug 2020 (actual)
Study completion: 30 May 2022 (estimated)
First posted: 18 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.

Detailed description

Primary Objectives

To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with relapsed and refractory POMES Syndrome.

Secondary Objectives

To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with POMES Syndrome.
To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
anti-CD19/BCMA CAR-T cells	Experimental	Biological: anti-CD19/BCMA CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideAdministration with anti-CD19/BCMA CAR-T cells in the relapsed and refractory POMES Syndrome patients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Expected survival > 12 weeks;
Diagnosis of POMES Syndrome;
The criteria for relapsed and refractory POMES Syndrome: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including Alkylating agent and other protein inhibitors (eg: Bortezomib), and have disease progression in the past 60 days;
At least 90 days after stem cell transplantation;
Creatinine≤2.0 mg/dl;

Key exclusion criteria (12 listed)

• In the first 5 years before screening, there are malignant tumors other than POMES Syndrome, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery，and catheter carcinoma in situ after radical surgery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anti-CD19/BCMA CAR-T cellsRetroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs	Biological	anti-CD19/BCMA CAR-T cells
Fludarabine30mg/m2/d	Drug	anti-CD19/BCMA CAR-T cells
Cyclophosphamide300mg/m2/d	Drug	anti-CD19/BCMA CAR-T cells

Primary outcome

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

2 secondary outcomes

Overall complete remission rate defined by the standard response criteria for POMES Syndrome
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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 6 Aug 2021. 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?

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 6 months). 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 NCT03879382.

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 6 Aug 2021.