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Relapsed/Refractory Multiple Myeloma(MM)MMNCT03473496

CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma

A study testing CART therapy in Relapsed/Refractory multiple myeloma in people with Relapsed/Refractory Multiple Myeloma(MM), run by Zhujiang Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma(MM)
What is being tested?
CART therapy in Relapsed/Refractory multiple myeloma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteChina
Study dates
1 Mar 2018to 31 Jan 2020
Phase
Interventional
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

  • Relapsed/Refractory MM patients
  • Cell phenotype is BCMA/CD138/CD38/CD56 positive (single or combined) ,and minimal residual disease (MRD) was positive(cytology, genetic testing)
  • Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky performance status(KPS) score is more than 60.
  • No cytapheresis and cell separation contraindication.
  • Hemoglobin is more than 80 gram per litre.
  • The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times normal range;(4)Alanine transaminase（ALT） and glutamic-oxalacetic transaminase（AST）is less than 3 times normal range,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
  • After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
  • Volunteered for this clinical trail and signed a consent form .

Who cannot join

  • Patients with high tumor burden or progression of disease need to control the progression of disease in order to decrease the tumor burden.
  • Patients with active infection and fever.
  • Patients' neutrophilic granulocyte has decreased more than 10 days,and is difficult to control after treatment.
  • Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
  • Patients with infection of HIV or with actively infection of Hepatitis B Virus(HBV) or Hepatitis C Virus(HCV).
  • Pregnant or lactating women.
Show all 11Show fewer
  • Patients with severe insufficient cardiac, pulmonary and hepatorenal functions.
  • Patients had been treated with cell therapy but was invalid.After analyzing the patient's condition , the expert group think that the patient doesn't fit to attend the therapy of CART.
  • The monoclonal antibodies of BCMA or CD38 are invalid for the patients who have used the drug.
  • Any situation may do harm to the subjects or interfere the results.
  • After allogeneic transplantation, patients are more than 3 degrees of acute Graft-Versus-Host disease(GVHD).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southern Medical University Zhujiang Hospital

    Guangdong, Guangdong, 510000

Other trials in China

About this study

Official title: The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Multiple Myeloma

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.

Read the detailed description

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.

In recent years, the understanding of pathogenic molecular mechanism in MM , many new types of drugs can be used in the treatment of this disease, one of the most widely used is proteasome inhibitors and immune regulator.Hematopoietic stem cell transplantation has also been shown to improve complete remission rates and prolong patient survival.Combined with the advantages of multiple therapies, chimeric antigen receptor T cells (CAR-T) have gradually become one of the strongest and most powerful weapons against multiple myeloma.

CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain.

When scFv recognizes antigens expressed in malignant cells, it stimulates the activation signal of downstream T cells and produces specific killing effects. CAR-T therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.Throughout registration of clinical trials and published research results, B-cell maturation antigen (BCMA) as one of targets , its effect is more significant than other molecules.As with BCMA antigens, cluster of differentiation 138(CD138), cluster of differentiation 56 (CD56) or cluster of differentiation 38(CD38) antigens are also highly expressed in multiple myeloma cells.With CD138 as the target for the treatment of CAR-T cells, several clinical studies have been registered, and the results show that some of them are effective.

In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 50 cases.The main content is safety, efficacy and feasibility analysis of the CAR-T cells （single CAR-T or double CAR-T cells with BCMA、CD138、CD56 or CD38 ) in the treatment of refractory/relapsed multiple myeloma.

Being tested
CART therapy in Relapsed/Refractory multiple myeloma
Keywords
BCMA-CART, CD138-CART, CD56-CART, CD38-CART
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CART therapy in Relapsed/Refractory multiple myelomaBiological

    one kind of BCMA/CD138/CD38/CD56-CART therapy in Relapsed/Refractory multiple myeloma

Study groups in NCT03473496
Study groupRoleWhat they receive
CART therapy in multiple myelomaExperimentalIn order to assess the safety and validity of using CAR-T therapy refractory/rela-psed multiple myeloma patients with one kind of BCMA-CART,CD138-CART,CD56-CART or CD38-CART,subjects will receive 10^6-10^7/Kg transduced CAR T cells at one time.
Receives: Biological: CART therapy in Relapsed/Refractory multiple myeloma

What is being measured

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

  1. Adverse events that Are related to treatment

    Determine the toxicity profile of the BCMA/CD138/CD38/CD56-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

    Measured: 2 years

Secondary outcomes (3)

  1. Estimate 2 year overall survival(OS) after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

    To estimate 2 year overall survival(OS) after BCMA/CD138/CD38/CD56-CART infusion and sequential treatment with Relapsed/Refractory MM

    Measured: 2 years

  2. Estimate 2 year relapse rate after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

    To estimate 2 year relapse rate after BCMA/CD138/CD38/CD56-CART infusion and sequential treatment with Relapsed/Refractory MM

    Measured: 2 years

  3. Estimate 2 year progression free survival after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

    To estimate 2 year progression free survival after BCMA/CD138/CD38/CD56-CART infusion and sequential treatment with Relapsed/Refractory MM

    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 posted22 Mar 2018
  2. Study start1 Mar 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Why it stopped: After CAR-T treatment, the benefit is not significant, and it is difficult to enroll.

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473496
Sponsor's protocol ID
2017-XYNK-003
Acronym
MM
Status last verified
Sep 2021
First submitted
15 Mar 2018
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CART therapy in Relapsed/Refractory multiple myeloma in people with Relapsed/Refractory Multiple Myeloma(MM), run by Zhujiang Hospital 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 8 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: stopped early, as of the sponsor's last update on 15 Mar 2024. 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.

Are results available for this study?

The study was stopped early (reason given: After CAR-T treatment, the benefit is not significant, and it is difficult to enroll.). 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?

Adverse events that Are related to treatment (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 NCT03473496.

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 15 Mar 2024.

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