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Multiple Myeloma in RelapsePhase 1NCT03767725

Anti-BCMA or/and Anti-CD19 CART Cells Treatment of Relapsed Multiple Myeloma

A Phase 1 study testing Treatment in people with Multiple Myeloma in Relapse, run by Shenzhen Second People's Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 phase I trial studies the side effects and best dose of BCMA CART cells in treating patients with BCMA positive multiple myeloma that have not respond to chemotherapy and autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT). Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Multiple Myeloma in Relapse
What is being tested?
Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
2 Jun 2018to 1 Sep 2021
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Have the capacity to give informed consent
  • Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
  • Serum M-protein >= 1 g/dL
  • Urine M-protein >= 200 mg/24 hour
  • Involved serum free light chain (sFLC) level >= 10 mg/dL with abnormal κ/λ ratio
  • Measurable biopsy-proven plasmacytomas (>= 1 lesion that has a single diameter >= 2 cm)
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  • Bone marrow plasma cells >= 30%
  • Have a diagnosis of BCMA+ multiple myeloma (MM) (>= 5% BCMA+ by flow cytometry on CD138 co-expressing plasma cells obtained within 45 days of study enrollment); the MM diagnosis must be confirmed by internal pathology review of a fresh biopsy specimen at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
  • Have relapsed or treatment refractory disease with >= 10% CD138+ malignant plasma cells (IHC) on bone marrow (BM) core biopsy, either:
  • Following autologous stem cell transplant (ASCT)
  • Or, if a patient has not yet undergone ASCT, the individual must:
  • Be transplant ineligible, due to age, comorbidity, patient choice, insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician, and,
  • Demonstrate disease that persists after > 4 cycles of induction therapy and that is double refractory (persistence/progression) after therapy with both a proteasome inhibitor and immunomodulatory drug (IMiD) administered either in tandem, or in sequence.

Who cannot join

  • Active hepatitis B, hepatitis C at the time of screening
  • Patients who are (human immunodeficiency virus [HIV]) seropositive
  • Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis
  • > 1 hospital admission for infection in prior 3 months
  • Presence of acute or chronic graft-versus-host disease (GVHD) unless limited to skin involvement and managed with topical steroid therapy alone
  • History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
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  • History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, active central nervous system MM involvement and/or carcinomatous meningitis; subjects with previously treated central nervous systems involvement may participate, provided they are free of disease in the CNS (documented by flow cytometry performed on the cerebrospinal fluid (CSF) within one week of enrollment) and have no evidence of new sites of CNS activity
  • Pregnant or nursing women; NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
  • Use of any of the following:
  • Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted
  • Allogeneic hematopoietic stem cell transplant (allo-HSCT) within 90 days of leukapheresis
  • Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis
  • Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide =< 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped >= 7 days prior to initiation of lymphodepleting chemotherapy
  • Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
  • Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the investigator; or unwillingness or inability to follow the procedures required in the protocol
  • Absolute neutrophil count (ANC) < 1.0×10E9/L, Hemoglobin (Hgb) < 80 g/L, Platelet count < 50×10E9/L
  • Active autoimmune disease requiring immunosuppressive therapy
  • Major organ dysfunction defined as:
  • Creatinine clearance < 20 ml/min
  • Significant hepatic dysfunction (serum glutamic-oxaloacetic transaminase [SGOT] or serum glutamic-oxaloacetic transaminase (SGOT) or serum alanine aminotransferase (SALT) > 5×upper limit of normal; bilirubin > 3.0 mg/dL)
  • Forced expiratory volume in 1 second (FEV1) of < 50% predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% (patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing)
  • Anticipated survival of < 3 months
  • Contraindication to cyclophosphamide or fludarabine chemotherapy
  • Patients with known AL subtype amyloidosis

Trial locations and contacts

1 site in 1 country.

Weihong Chen, M.D. contact

86-755-83366388 ext. 8199

whitney-cindy@hotmail.com

Xin Du, M.D. contact

86-755-83366388 ext. 8197

duxingz@medmail.com.cn

China1 site, 1 recruiting

  • Shenzhen Second People's Hospital,The first affiliated hospital of Shenzhen University

    Shenzhen, Guangdong, 518035

    Weihong Chen, 86-755-83366388 ext. 8199, whitney-cindy@hotmail.com

    Xin Du, 86-755-83366388 ext. 8197, duxingz@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: Phase I Trial Study of Anti-BCMA (B-cell Maturation Antigen) or/and Anti-CD19 Chimeric Antigen Receptor T Cells (CART Cell) Treatment for the Patient of Relapsed Multiple Myeloma

This phase I trial studies the side effects and best dose of BCMA CART cells in treating patients with BCMA positive multiple myeloma that have not respond to chemotherapy and autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT). B-cell maturation antigen (BCMA), a cell surface protein expressed on mutiple maloma cells, has emerged as a very selective antigen to be targeted in novel immunotherpy for MM. Targeting postulated CD19 positive myeloma stem cells with anti-CD19 CAR-T cells is a novel approach to MM therapy.

Read the detailed description

This is multi-center, phase I trial that studies the side effects and best dose of BCMA CART cells in treating patients with BCMA positive multiple myeloma that have not respond to chemotherapy and autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT). B-cell maturation antigen (BCMA), a cell surface protein expressed on mutiple maloma cells , has emerged as a very selective antigen to be targeted in novel immunotherpy for MM. Targeting postulated CD19+ myeloma stem cells with anti-CD19 CAR-T cells is a novel approach to MM therapy.

Being tested
Treatment
Keywords
Anti-BCMA, Anti-CD19, CART cell, treatment, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • TreatmentBiological

    Phase 1 Clinical Study of The patients undergo leukapheresis. The patients then receive fludarabine and cyclophosphamide on days-5 to-3. Subjects will receive (0.6-60)x10E8 transduced CART cells as a split dose over three days as follows: Day 0, 10% fraction: (0.06-6)x10E8 CART19 cells, Day 1, 30% fraction: (0.18-18)x10E8 CART19 cells, Day 2, 60% fraction: (0.36-36)x10E8 CART cells.

Study groups in NCT03767725
Study groupRoleWhat they receive
TreatmentExperimentalPhase 1 Clinical Study of The patients undergo leukapheresis. The patients then receive fludarabine and cyclophosphamide on days-5 to-3. Subjects will receive (0.6-60)x10E8 transduced CART cells as a split dose over three days as follows: Day 0, 10% fraction: (0.06-6)x10E8 CART19 cells, Day 1, 30% fraction: (0.18-18)x10E8 CART19 cells, Day 2, 60% fraction: (0.36-36)x10E8 CART19 cells.
Receives: Biological: Treatment

What is being measured

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

  1. No Dose-limiting toxicity

    No Dose-limiting toxicity

    Measured: up to 5 mouths after T cell infusion

Timeline

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

  1. First posted7 Dec 2018
  2. Study start2 Jun 2018
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Sep 2021 (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
Model description
Anti-BCMA or/and Anti-CD19 CAR Autologous T Cells
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767725
Sponsor's protocol ID
Weihong Chen06082018
Status last verified
Dec 2018
First submitted
5 Dec 2018
Last updated
10 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment in people with Multiple Myeloma in Relapse, run by Shenzhen Second People's 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 13 inclusion and 25 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 10 Dec 2018. 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?

Contact Weihong Chen, M.D. (86-755-83366388 ext. 8199, whitney-cindy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No Dose-limiting toxicity (time frame: up to 5 mouths after T cell infusion). 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 NCT03767725.

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 10 Dec 2018.

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