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Relapsed or Refractory Multiple MyelomaPhase 1NCT04706936

Novel BCMA-targeted CAR-T Cell Therapy for Multiple Myeloma

A Phase 1 study testing anti-BCMA CAR-T, Cyclophosphamid and Fludarabine in people with Relapsed or Refractory Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study evaluates the safety and efficacy of novel BCMA-targeted CAR-T cell therapy (CBG-002) for patients with relapsed or refractory multiple myeloma (r/r MM). CBG-002 is designed based on the fourth-generation of CAR-T techonology. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
anti-BCMA CAR-T, Cyclophosphamid and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Apr 2021to Apr 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with relapsed/refractory multiple myeloma aged 18-75 years;
  • BCMA expression ≥50% in bone marrow samples confirmed by Flow Cytometry or IHC is positive for BCMA expression;
  • Relapsed/refractory patients who meet the following conditions:
  • Ineffective or disease progression after receiving bortezomib (proteasome inhibitor) and lenalidomide for 3 courses;
  • Ineffective or disease progression after receiving the original treatment plan for 3 courses;
  • The interval between the last treatment and disease progression is more than 30 days;
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  • There is currently no indication for hematopoietic stem cell transplantation, or the patient refuses to do hematopoietic stem cell transplantation;
  • The definition of disease progression refers to the "2014 IMWG Standards", and at least meets the following 1 items:
  • e.1 Serum M protein ≥ 0.5 g/dL;
  • e.2 Urine M protein ≥ 200 mg/24 h;
  • e.3 If the serum FLC ratio is abnormal, the patient's FLC level ≥ 10 mg/dL (100 mg/L);
  • e.4 Evaluable plasmacytoma confirmed by biopsy;
  • e.5 Increase in the proportion of bone marrow plasma cells ≥25% (absolute increase ≥10%);
  • e.6 Bone marrow plasma cells account for 30% of the total bone marrow cells;
  • Estimated survival time> 12 weeks;
  • The disease status can be assessed and meet at least one of the following:
  • Serum M-protein ≥10 g/L;
  • 24h urine M-protein ≥200mg;
  • Serum FLC≥5mg/dL;
  • Plasma cell tumors that can be assessed by testing or images;
  • The proportion of bone marrow plasma cells ≥ 30%;
  • ECOG physical status score 0-1;
  • Have enough venous access for apheresis or venous blood collection, and there are no other contraindications for blood cell separation;
  • WBC ≥ 1.5×109/L; PLT ≥ 45×109/L;
  • Serum creatinine ≤ 1.5 upper limit of normal (ULN) ;
  • ALT ≤ 2.5 ULN, AST ≤ 2.5 ULN.
  • All laboratory test results within the above range should have no ongoing continuous supportive treatment.

Who cannot join

  • -
  • Subjects who meet any of the following criteria cannot be selected for this study:
  • Systemic treatment such as lymphatic depletion with cyclophosphamide and fludarabine within 2 weeks before enrollment or single cell collection, or cell therapy within 8 weeks before treatment;
  • HCV or HIV positive; any uncontrollable active infection, including active tuberculosis, HBV DNA level ≥1×103 copies/mL;
  • Active infections occurred within 72 hours before cleansing; as long as there is no evidence of active infection and antibiotics are not in the list of prohibited drugs, subjects who continue to use preventive antibiotics, antifungal drugs or antiviral drugs are not excluded;
  • The current systemic use of cyclosporine or steroid drugs such as dexamethasone, recent or current use of inhaled steroids is not excluded;
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  • Renal insufficiency, serum creatinine>1.5 upper limit of normal (ULN);
  • Liver insufficiency, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 times ULN and direct bilirubin>1.5 times ULN;
  • Hyponatremia, blood sodium <125 mmol/L;
  • Baseline serum potassium <3.5 mmol/L (potassium supplementation can be given before participating in the study, and serum potassium recovery above this standard is not excluded);
  • Pregnant or lactating women;
  • Other serious diseases that may restrict subjects from participating in this trial (such as central nervous system disease, severe heart insufficiency, myocardial obstruction or unstable arrhythmia or unstable angina, gastric ulcer in the past 6 months , Active autoimmune diseases, etc.).

Trial locations and contacts

1 site in 1 country.

Wenbin Qian contact

13605801032

qianwb@zju.edu.cn

China1 site, 1 recruiting

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

    Wenbing Qian, M.D.,PhD., +8613605801032, qianwb@zju.edu.cn

    Recruiting

Other trials in China

About this study

This study evaluates the safety and efficacy of novel BCMA-targeted CAR-T cell therapy (CBG-002) for patients with relapsed or refractory multiple myeloma (r/r MM). CBG-002 is designed based on the fourth-generation of CAR-T techonology.

Being tested
anti-BCMA CAR-T, Cyclophosphamid, Fludarabine
Keywords
BCMA, Chimeric antigen receptor T cell, Adoptive cell therapy
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

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

  • anti-BCMA CAR-TBiological

    Also called CBG-002 CAR-T

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

  • CyclophosphamidDrug

    300mg/m2/d

  • FludarabineDrug

    30mg/m2/d

Study groups in NCT04706936
Study groupRoleWhat they receive
Anti-BCMA CAR-T (CBG-002)ExperimentalAll subjects were intravenous administrated with CBG-002.
Receives: Biological: anti-BCMA CAR-T; Drug: Cyclophosphamid; Drug: Fludarabine

What is being measured

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

  1. Rate of grade 3 or 4 treatment related adverse effect

    All the CAR-T treatment related adverse events，including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.

    Measured: 24 weeks after last dose of CAR-T treatment

  2. Overall response rate (ORR) after treated by CAR-T treatment

    ORR will be assessed and graded by the international Myeloma Working Group (IMWG) Unified response criteria for multiple myeloma

    Measured: up to 2 years after CAR-T treatment

Secondary outcomes (3)

  1. Pharmacokinetics of CAR-T cells (implantation endpoint)

    To assess the duration of CAR-positive T cells in circulation, the copy number of CAR DNA was measured at the preset follow-up time point. The time when the results of any two consecutive tests were negative, were recorded as the "implantation endpoint".

    Measured: up to 2 years after CAR-T treatment

  2. Overall survival

    From date of inclusion to date of progression, relapse, or death from any cause.

    Measured: up to 2 years after CAR-T treatment

  3. Progression free survival

    The length of time that a participant's disease did not progress during and after CAR-T treatment.

    Measured: up to 2 years after CAR-T treatment

Timeline

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

  1. First posted13 Jan 2021
  2. Study start1 Apr 2021
  3. Primary completionOct 2023 (estimated)
  4. Study completionApr 2024 (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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706936
Sponsor's protocol ID
IR2020001474
Status last verified
Feb 2023
First submitted
3 Dec 2020
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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, Cyclophosphamid and Fludarabine in people with Relapsed or Refractory Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang 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 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 Feb 2023. 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 Wenbin Qian (13605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of grade 3 or 4 treatment related adverse effect (time frame: 24 weeks after last dose of CAR-T treatment). The study lists 2 primary outcomes in all. 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 NCT04706936, 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 6 Feb 2023.

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