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Refractory or Relapsed Multiple MyelomaNCT03380039

Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma

A study testing CAR-BCMA T cells, Fludarabine and Cyclophosphamide in people with Refractory or Relapsed Multiple Myeloma, run by Xinhua Hospital, Shanghai Jiao Tong University School of 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Refractory or Relapsed Multiple Myeloma
What is being tested?
CAR-BCMA T cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
13 Oct 2017to 2 Jul 2023
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18 ~ 70 with relapsed or refractory multiple myeloma.
  • Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
  • Patients with relapsed or refractory multiple myeloma who meet the following conditions:
  • 1) Curative efficacy is little or disease progressed after 2 courses of standard treatment regimen;
  • 2) Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen;
  • 3) More than 60 days between last treatment and disease progression;
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  • 4) Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT;
  • 5) Disease progression is defined as per "Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revision in 2015)". At least one of the following conditions should be met:
  • - i. Serum M-protein increases ≥ 25% (absolute increase should be ≥ 5 g/L). If serum M protein is ≥ 50 g/L at baseline, increase of serum M protein can be ≥ 10 g/L;
  • - ii. Urine M-protein increases ≥ 25% (absolute increase should be ≥ 200 mg/24 h);
  • - iii. If the serum and urine M-protein are not detectable, a ≥ 25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be ≥ 100 mg/L);
  • - iv. Bone marrow plasma cell percentage increases ≥ 25% (absolute increase should be ≥ 10%);
  • - v. Size of existing bone lesions or soft tissue plasmacytomas increases by ≥ 25%, or development of new lytic bone lesions or soft tissue plasmacytomas;
  • - vi. Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is > 2.8 mmol/L or 11.5 mg/dL);
  • - vii. Disease progression must be confirmed by 2 sequential assessments.
  • Expected survival > 12 weeks.
  • Disease is measurable, and at least one of the following conditions should be satisfied:
  • 1) Serum M-protein is ≥ 10 g/L;
  • 2) 24-hour urine M-protein is ≥ 200 mg;
  • 3) Serum FLC is ≥ 5 mg/dL;
  • 4) Plasmacytomas that can be measured or evaluated by imaging;
  • 5) Bone marrow plasma cell percentage is ≥ 20%.
  • ECOG scores 0 - 1.
  • Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis.
  • WBC ≥ 1.5×10^9/L, PLT ≥ 45×10^9/L;
  • Serum creatinine ≤ 1.5 ULN.
  • ALT ≤ 2.5 ULN, AST ≤ 2.5 ULN. The above lab results should not include those obtained from continuous supportive treatment that is ongoing.

Who cannot join

  • Patients with any of the following conditions are not eligible for this study.
  • Transduction of target lymphocytes < 10%, expansion in response to αCD3/CD28 costimulation < 5-fold.
  • Pregnant or lactating women.
  • HIV positive, or HCV positive
  • Uncontrolled active infection, including active tuberculosis and HBV DNA copies ≥ 1×10^3 copies/mL.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
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  • Allergic to immunotherapies and related drugs.
  • Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
  • Hyponatremia: serum sodium level < 125 mmol/L.
  • Baseline serum potassium < 3.5 mmol/L (taking potassium supplements before participating in the study to raise potassium level is acceptable).
  • Previous treatment with chemoradiotherapy, immunotherapy and tumor-targeting drug conducted 2 weeks prior to participation in this study or blood collection.
  • Patients have undertaken immunosuppressor for graft-versus-host disease (GVHD) within 4 weeks before participation in this study or blood collection, or the patient is diagnosed with acute or chronic GVHD.
  • Other severe disease that may restrain patients from participating in this study (e.g. diabetes, severe cardiac dysfunction, myocardial infarction or unstable arrhythmias or unstable angina in recent 6 months, gastric ulcer, active autoimmune disease, etc.).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xin Hua Hospital of Shanghai Jiao Tong University of Medicine

    Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

Official title: Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma

A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.

Read the detailed description

This study is designed to determine the safety, tolerability and engraftment potential of anti-BCMA lentivirus-transduced autologous T cells in patients with refractory or relapsed multiple myeloma.

Primary objectives:

  1. Determine the safety and tolerability of CAR-BCMA T cells (autologous T cells transduced with chimeric antigen receptors recognizing BCMA) in patients with refractory or relapsed multiple myeloma.
  2. Observe the cytokinetics of CAR-BCMA T cells.

Secondary objectives:

  1. Observe the anti-tumor response of CAR-BCMA T cells to refractory or relapsed multiple myeloma (evaluated by diagnostic criteria International Myeloma Working Group (IMWG2014 version) as CR, sCR, ICR, MCR or VGPR).
  2. Make an evaluation on the distribution and in vivo survival of CAR-BCMA T cells in peripheral blood, lymph node, and bone marrow.
  3. Observe the immunogenicity of CAR-BCMA T cells, and determine if there is anti-BCMA scFv cellular immune response and anti-BCMA scFv humoral immune response.
  4. Observe the changes of cell subsets of CAR-BCMA T cells against T cells (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T lymphocytes).
Being tested
CAR-BCMA 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.

  • CAR-BCMA T cellsGenetic

    Also called BCMA-redirected autologous T cells

    Single dose of CAR-BCMA T cells will be infused, and classic "3+3" dose escalation will be applied.

  • FludarabineDrug

    Fludarabine is used for lymphodepletion.

  • CyclophosphamideDrug

    Cyclophosphamide is used for lymphodepletion.

Study groups in NCT03380039
Study groupRoleWhat they receive
CAR-BCMA T cellsExperimentalIn this study, autologous T cells transduced with a BCMA-targeted chimeric antigen receptor (CAR-BCMA T cells) are used to treat patients with refractory or relapsed multiple myeloma. Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to CAR-BCMA T cells infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
Receives: Genetic: CAR-BCMA T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. Number of participants with CAR-BCMA T cell therapy-related adverse events as assessed by CTCAE v4.03

    Number of participants with study related adverse events which are defined as laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment at any time from the infusion until week 24, including infusion related toxicity and any toxicity possibly related to CAR-BCMA T cells.

    Measured: 24 weeks

Secondary outcomes (6)

  1. Engraftment

    Duration of in vivo survival of CAR-BCMA T cells is defined as "engraftment". The primary engraftment endpoint is the number of CAR-BCMA DNA vector copies per mL blood of CAR-BCMA T cells at regular intervals from 24 hours after initial infusion through 2 years of last infusion. PCR for CAR-BCMA T vector sequences will be performed until any 2 sequential tests are negative, documented as engraftment of CAR-BCMA T cells.

    Measured: 2 years

  2. Anti-tumor response of CAR-BCMA T cell infusion

    Observe the anti-tumor response of CAR-BCMA T cells to refractory or relapsed multiple myeloma (evaluated by diagnostic criteria International Myeloma Working Group (IMWG2014 version) as CR, sCR, ICR, MCR or VGPR).

    Measured: 2 years

  3. Statistical parameter of efficacy assessment#PFS

    Statistical parameter#Progression-free Survival (PFS)

    Measured: 5 years

  4. Statistical parameter of efficacy assessment#DCR

    Statistical parameter:Disease Control Rate (DCR)

    Measured: 2 years

  5. Statistical parameter of efficacy assessment#ORR

    Statistical parameter:Objective Remission Rate (ORR)

    Measured: 2 years

  6. Statistical parameter of efficacy assessment#OS

    Statistical parameter:Overall survival (OS)

    Measured: 5 years

Timeline

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

  1. First posted20 Dec 2017
  2. Study start13 Oct 2017
  3. Primary completion2 Jul 2020
  4. Study completion2 Jul 2023 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03380039
Sponsor's protocol ID
XH-17-018
Status last verified
Sep 2020
First submitted
11 Dec 2017
Last updated
12 Oct 2020
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 CAR-BCMA T cells, Fludarabine and Cyclophosphamide in people with Refractory or Relapsed Multiple Myeloma, run by Xinhua Hospital, Shanghai Jiao Tong University School of 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 27 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: status not confirmed, as of the sponsor's last update on 12 Oct 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.

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?

Number of participants with CAR-BCMA T cell therapy-related adverse events as assessed by CTCAE v4.03 (time frame: 24 weeks). 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 NCT03380039.

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 12 Oct 2020.

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