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RelapsedEarly Phase 1NCT06732232

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma

A Early Phase 1 study testing CD19/CD20/BCMA CAR-T in people with Relapsed and Refractory, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed, Refractory, Multiple Myeloma
What is being tested?
CD19/CD20/BCMA CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
12 Dec 2024to 12 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Participants must meet all of the following criteria in order to be enrolled:
  • Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations/procedures;
  • Age range: 18-75 years old;
  • Expected survival period is not less than 12 weeks;
  • ECOG score ≤ 2 points;
  • The bone marrow flow cytometry results showed positive BCMA antigen (including weak positive, moderate positive, and strong positive);
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  • According to the IMWG criteria, a diagnosis of multiple myeloma with measurable lesions must meet at least one of the following criteria:
  • Serum M protein (SPEP) ≥ 5g/L
  • 24-hour urinary M-protein excretion rate ≥ 0.2g (200mg)
  • Serum free light chain (sFLC) ≥ 100 mg/L and abnormal free light chain ratio
  • The ratio of primitive plasma cells to immature plasma cells in bone marrow cytology examination is greater than 5%, or the flow cytometry detection of monoclonal plasma cells is greater than 5%
  • Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed, and have experienced relapse (within 12 months), difficulty in treatment, or intolerance to the last line treatment regimen, including primary difficulty in treatment (subjects who have not achieved minimal remission [MR] or developed disease progression [PD] during treatment) or secondary difficulty in treatment (subjects who develop disease progression within 60 days after completion of treatment);
  • There is no significant abnormality in lung function, and the oxygen saturation is greater than 92% in the absence of oxygen inhalation;
  • The blood biochemistry test results meet the following criteria:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 × ULN
  • 24-hour serum creatinine clearance rate ≥ 30 mL/min
  • Lipase and amylase ≤ 2 × ULN
  • The blood routine test meets the following criteria:
  • Lymphocyte count>0.5 × 10 ^ 9/L
  • Neutrophil count ≥ 1.0 × 10 ^ 9/L
  • Hemoglobin ≥ 60g/L
  • Platelets ≥ 40 × 10 ^ 9/L
  • Men with fertility and women of childbearing age must agree to use effective contraceptive measures from the signing of the informed consent form until 2 years after the use of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test for women of childbearing age must be negative during screening.

Who cannot join

  • Any of the following situations cannot be selected as a subject:
  • Asymptomatic (smoking type) multiple myeloma;
  • Multiple myeloma with only extramedullary lesions present;
  • Plasma cell leukemia;
  • Merge amyloidosis;
  • Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression;
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  • Pregnancy or lactation period;
  • Individuals who are HBsAg positive or HBcAb positive, unless HBV-DNA is less than 100 IU/ml or below the minimum detectable value; Individuals who are positive for hepatitis C virus (HCV) antibodies and HCV-RNA; Individuals who are HIV antibody positive; Individuals who are positive for syphilis specific antibodies and have a positive TRUST (toluidine red unheated serum test) test; Individuals who test positive for Cytomegalovirus (CMV) DNA;
  • Cardiovascular diseases with clinical significance, including any of the following:
  • QT interval (QTcF) after heart rate correction:>470 milliseconds;
  • New York Heart Association Grade II and above heart failure;
  • Left ventricular ejection fraction (LVEF) ≤ 50%;
  • Poorly controlled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 95 mm Hg)
  • Arrhythmias that have clinical significance or require antiarrhythmic treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion tachycardia, and complete left bundle branch block);
  • Has experienced unstable angina or acute myocardial infarction within the 6 months prior to signing the ICF;
  • Previously received any anti-CD45 or anti-CD3 treatment;
  • Individuals who are allergic to any of the components of the drugs used in this study, including but not limited to Qing Lin drugs (cyclophosphamide, fludarabine), etc;
  • Received any investigational drug or systemic anti-tumor treatment within 4 weeks (or 5 half lives of the drug, whichever the researcher deems more appropriate) prior to single collection;
  • History of other primary malignant tumors within 5 years prior to treatment, except for the following situations:
  • Fully treat cured cervical carcinoma in situ;
  • Localized basal cell carcinoma or squamous cell carcinoma of the skin;
  • Any uncontrolled active infection within 4 weeks prior to single collection requires parenteral antibiotics, antiviral or antifungal treatment;
  • Individuals with a history of active pulmonary tuberculosis infection within one year prior to single sampling (excluding subjects with a history of active pulmonary tuberculosis infection more than one year ago who, according to the researcher's judgment, currently have no evidence of active pulmonary tuberculosis);
  • Accompanying or having a history of interstitial lung disease or interstitial pneumonia;
  • Subjects who receive autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of signing the ICF, or who plan to undergo ASCT during the study period;
  • Subjects who have received allogeneic stem cell therapy in the past; The researchers believe that complications or other conditions in the subjects may affect their compliance with the protocol or make them unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinxing Lou contact

0086-021-67091399

loujx@shcell.com

Jinxing Lou contact

loujx@shcell.com

China1 site, 1 recruiting

  • China, Shanghai Mengchao Cancer Hospital

    Shanghai

    j x Lou, 0086-18911335396, loujx@shcell.com

    Recruiting

Other trials in China

About this study

Official title: A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.

Read the detailed description

This is a single arm, open-label, dose escalation investigator initiated (IIT) study, the primary objective is to evaluate the safety and tolerability of CD19/ CD22/BCMA CAR-T therapy in patients with relapsed/refractory multiple myeloma, and determine the maximum tolerated dose (MTD). For the secondary objectives,pharmacokinetics(PK), survival of CAR-T cells in vivo,pharmacodynamics (PD) and efficacy in R/R MM will be evaluated.

This study flow comprises of a screening phase( 30 to10 days prior to infusion), apheresis phase (9 to 8 days prior to infusion), lymphodepletion phase (5 to 3 days prior to infusion) , infusion of CD19/CD22/BCMA CAR-T cells on Day0, DLT assessments phase (from Day1 to Day 28) and post- treatment follow-up phase (Day 29 and up to end of the study).

Being tested
CD19/CD20/BCMA CAR-T
Keywords
relapsed/refractory multiple myeloma, CAR-T, CD19, CD22, BCMA
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.

  • CD19/CD20/BCMA CAR-TDrug

    CD19/CD20/BCMA CAR T therapy

Study groups in NCT06732232
Study groupRoleWhat they receive
CD19/CD20/BCMA CAR-T cells therapyExperimentalCD19/CD20/BCMA CAR T cells Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells. Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection
Receives: Drug: CD19/CD20/BCMA CAR-T

What is being measured

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

  1. Dose-limiting toxicity(DLT)

    Safety

    Measured: [Time Frame: Day0-Day28]

  2. Maximum tolerated dose (MTD)

    Evaluate the incidence, severity, and correlation of SAE Tolerability

    Measured: [Time Frame: Day0-Day28]

Secondary outcomes (16)

  1. Maximum Plasma Concentration(Cmax)

    Pharmacokinetics(PK)

    Measured: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]

  2. Maximum Plasma Concentration Time (Tmax)

    Pharmacokinetics(PK)

    Measured: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]

  3. Area Under Curve (AUC)

    Pharmacokinetics(PK)

    Measured: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]

  4. CAR positive T cells

    Pharmacokinetics(PK)

    Measured: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]

  5. Cytokines ( IL(interleukin)-2）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  6. Cytokines ( IL(interleukin)-4）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  7. Cytokines ( IL(interleukin)-6）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  8. Cytokines ( IL(interleukin)-8）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  9. Cytokines ( IL(interleukin)-10）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  10. Cytokines ( IL(interleukin)-15）

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  11. IFN(interferon)-γ

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  12. TNF(tumor necrosis factor)-α

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  13. MCP( monocyte chemoattractant protein)-1)

    Pharmacodynamics (PD)

    Measured: [Time Frame:Day0-Day28]

  14. Overall survival (OS)

    Based on the analysis of MRD negative rate by researchers according to IMWG standards

    Measured: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]

  15. Progression-free survival (PFS)

    Based on the analysis of MRD negative rate by researchers according to IMWG standards

    Measured: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]

  16. Minor residual diseases(MRD)

    Based on the analysis of MRD negative rate by researchers according to IMWG standards

    Measured: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]

Timeline

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

  1. First posted13 Dec 2024
  2. Study start12 Dec 2024
  3. Primary completion12 Dec 2027 (estimated)
  4. Study completion12 Dec 2027 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732232
Sponsor's protocol ID
BZE2204-B-01
Status last verified
Nov 2024
First submitted
28 Nov 2024
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD19/CD20/BCMA CAR-T in people with Relapsed and Refractory, run by Shanghai Cell Therapy Group Co.,Ltd 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 24 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 13 Dec 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinxing Lou (0086-021-67091399, loujx@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) (time frame: [Time Frame: Day0-Day28]). 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 NCT06732232.

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 13 Dec 2024.

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