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Multiple MyelomaPhase 1NCT03093168

BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma

A Phase 1 study testing Anti-BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Anti-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
15 Feb 2017to Feb 2020
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Expected survival > 12 weeks
  • Diagnosis of Multiple Myeloma by MWG criteria 20
  • Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
  • Important organs function enough to tolerate this therapy
  • At least 90 days after stem cell transplantation
  • Clinical performance status of ECOG score 0-4
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  • 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
  • Able to understand and sign the Informed Consent Document.

Who cannot join

  • Patients with symptoms of central nervous system
  • Patients with second malignancies in addition to multiple myeloma
  • Active hepatitis B or C, HIV infections
  • Any other active diseases could affect the enrollment of this trial
  • Suffering severe cardiovascular or respiratory disease
  • Poorly controlled hypertension
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  • Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
  • A history of mental illness and poorly controlled
  • Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
  • Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  • Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
  • Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Active systemic infections or uncontrolled infection within 14 days prior enrollment
  • Subjects suffering disease affects the understanding of informed consent or complying with study protocol

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Henan Province of TCM

    Zhengzhou, Henan

    Zhi Cheng, M.D., +(86)-139-3852-6995, clinicaltrials.chengzhi@outlook.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma

The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.

Read the detailed description

Primary Objectives

  1. To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
  2. To determine in vivo dynamics and persistency of BCMA CAR-T cells.
  3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.

Secondary Objectives

  1. To assess the bone marrow and tumor migration of BCMA CAR-T cells.
  2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro
  3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
  4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
Being tested
Anti-BCMA CAR-T cells, Fludarabine, Cyclophosphamide
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Anti-BCMA CAR-T cellsBiological

    Retroviral vector-transduced autologous T cells to express anti-BCMA CAR

  • FludarabineDrug

    dose: 25mg/m2/d

  • CyclophosphamideDrug

    Dose: 40mg/kg

Study groups in NCT03093168
Study groupRoleWhat they receive
anti-BCMA CAR-TExperimentalAdministration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
Receives: Biological: Anti-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.

  1. 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 (3)

  1. Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    Measured: 8 weeks

  2. Duration of CAR-positive T cells in circulation

    Duration of CAR-positive T cells in circulation

    Measured: 6 months

  3. Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Measured: 6 months

Timeline

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

  1. First posted28 Mar 2017
  2. Study start15 Feb 2017
  3. Primary completionSep 2019 (estimated)
  4. Study completionFeb 2020 (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
NCT03093168
Sponsor's protocol ID
anti-BCMA CART
Status last verified
Mar 2018
First submitted
15 Mar 2017
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

    PubMed 37192741

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine 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 9 inclusion and 14 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 27 Feb 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?

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?

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 NCT03093168, which also lists 1 linked publication.

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 27 Feb 2019.

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