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Multiple MyelomaEarly Phase 1NCT05302648

To Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with R/R MM

A Early Phase 1 study testing Human Derived anti-BCMA CAR-T Injection in people with Multiple Myeloma, run by Hrain Biotechnology Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human Derived anti-BCMA CAR-T Injection , and to preliminarily observe the efficacy of the trial drug 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
Multiple Myeloma
What is being tested?
Human Derived anti-BCMA CAR-T Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
9 Feb 2022to 31 Dec 2025
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

  • Subjects must meet all of the following criteria to be enrolled:
  • Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
  • 18 to 75 years old (including cut-off value), Male and female;
  • Expected survival > 12 weeks;
  • Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
  • One of the following indicators is satisfied:
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  • Serum M protein: for immunoglobulin G (IgG) type , M protein≥ 10 g/L, or for immunoglobulin A (IgA) type , M protein > 5g/L, or for immunoglobulin D (IgD) type , M protein, IgD exceeds upper limit of normal range.
  • Urine M protein ≥ 200 mg/24h;
  • Serum free light chain ≥ 100 mg/L and Serum free light chain ratio is abnormal ;
  • Patients with relapsed/refractory multiple myeloma. Relapsed is defined as: Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators; Refractory is defined as: Patients who achieved minimal response(MR) or above was never achieved in previous treatment; MR or above was achieved in previous treatment, but disease progression occurred during subsequent treatment or within 60 days after the last treatment.
  • ECOG score 0-2;
  • Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
  • Left ventricular ejection fraction >50%;
  • Baseline peripheral oxygen saturation >95%;
  • Total bilirubin ≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
  • The venous access required for collection can be established and leukepheresis can be carriedaccording to the judgement of investigators.

Who cannot join

  • Any one of the following conditions cannot be selected as a subject：
  • Accompanied by other uncontrolled malignancies;
  • Subjects with positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B virus(HBV) DNA titer is ≥500IU/mL; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus(HIV) antibody positive; syphilis primary screening antibody positive;
  • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure （New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
  • Patients who are accounted to be not appropriate for this trail by investigator;
  • Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
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  • Received CAR-T treatment or other gene therapies before enrollment;
  • Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements;
  • Have had severe immediate hypersensitivity reactions to any drugs used in this research;
  • Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
  • In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
  • Patients with symptoms of central nervous system.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200005

Other trials in China

About this study

Official title: A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with Relapsed/Refractory Multiple Myeloma

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human Derived anti-BCMA CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma.

Read the detailed description

Subjects withe relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography（CT）/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography（PET）,liver/renal function tests, complete blood count with differential and complete metabolic profile and etc.. Subjects will receive precondtioning chemotherapy prior to the infusion of BCMA CAR- T cells. After the infusion, subjects will be followed for adverse events pharmacokinetic/pharmacodynamics characteristics, efficacy, of BCMA CAR-T cells. Study procedures may be performed while hospitalized.

Being tested
Human Derived anti-BCMA CAR-T Injection
Keywords
BCMA, CAR-T, multiple myeloma, Relapsed /Refractory
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Human Derived anti-BCMA CAR-T InjectionDrug

    Also called BCMA CAR-T

    Autologous genetically modified anti-BCMA CAR transduced T cells

Study groups in NCT05302648
Study groupRoleWhat they receive
Human Derived anti-BCMA CAR-T InjectionExperimentalSingle administration：1.0×10^6 CAR+T, 3.0×10^6 CAR+T, 6.0×10^6 CAR+T
Receives: Drug: Human Derived anti-BCMA CAR-T Injection

What is being measured

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

  1. Dose limited toxicity(DLT)

    Safety Indicator

    Measured: 28 days post infusion

Secondary outcomes (15)

  1. Pharmacokinetics parameters - Maximum CAR level in blood and CAR level in bone marrow(Cmax)

    Effectiveness Metrics

    Measured: 2 years post infusion

  2. Pharmacokinetics parameters -Time to peak CAR level in blood (Tmax)

    Effectiveness Metrics

    Measured: 2 years post infusion

  3. Pharmacokinetics parameters - 28-day Area under the curve of the CAR level in blood(AUC0-28)

    Effectiveness Metrics

    Measured: 2 years post infusion

  4. Pharmacodynamics characteristics - Cytokines Concentrations,cytokines level in blood

    Effectiveness Metrics

    Measured: 2 years post infusion

  5. Pharmacodynamics characteristics -Clonal bone marrow plasma cells level

    Effectiveness Metrics

    Measured: 2 years post infusion

  6. Overall Response Rate (ORR) at 3 month post infusion

    ORR defined as proportion of subjects who achieved Partial remission(PR) or better according to the International Myeloma Working Group response criteria (2016) (IMWG 2016) as determined by an Investigator assessment at 3 month post infusion.

    Measured: 3 month post infusion

  7. Percentage of Subjects With Negative Minimal Residual Disease (MRD)

    MRD negative rate is defined as the proportion of subjects who achieve MRD negative status

    Measured: 2 years post infusion

  8. Duration of Subjects With Negative Minimal Residual Disease (MRD)

    MRD duration will calculated among MRD negative responders fom the date of initial MRD negative to the date of first documented evidence of MRD positive, as defined in the IMWG criteria (2016).

    Measured: 2 years post infusion

  9. Number of Subjects with Adverse Events

    Adverse event is any untoward medical event that occurs in a subject administered an investigational drug.

    Measured: 2 years post infusion

  10. Change from Baseline in Perform Status as Measured by Eastern Cooperative Oncology Group（ECOG）Score（0-4）

    Eastern Cooperative Oncology Group（ECOG） Performance Status Score（0-4） will be assessed by the inverstigator at baseline and the respective time point, higher scores mean a worse performance status.

    Measured: 2 years post infusion

  11. Change from Baseline in complete blood count with differential and blood biochemical examination

    complete blood count with differential and blood biochemical examination will be assessed by the investigator at the respective time point.

    Measured: 2 years post infusion

  12. Change from Baseline in Physical Exam

    physical exam will be assessed by the inverstigator at the respective time poin.

    Measured: 2 years post infusion

  13. Progression-free Survival (PFS)

    PFS defined as time from date of initial infusion of CAR-T to date of first disease progression according to IMWG criteria (2016) , or death due to any cause, whichever occurs first.

    Measured: 2 years post infusion

  14. Overall Survival (OS)

    OS is measured from the date of the initial infusion of CAR-T to the date of the subject's death.

    Measured: 2 years post infusion

  15. Duration of Response (DOR)

    DOR will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2016).

    Measured: 2 years post infusion

Timeline

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

  1. First posted31 Mar 2022
  2. Study start9 Feb 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025 (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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302648
Sponsor's protocol ID
HRAIN01-MM03-POC
Status last verified
Dec 2024
First submitted
3 Mar 2022
Last updated
3 Jan 2025
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 Early Phase 1 study testing Human Derived anti-BCMA CAR-T Injection in people with Multiple Myeloma, run by Hrain Biotechnology 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 17 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. 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?

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?

Dose limited toxicity(DLT) (time frame: 28 days post 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 NCT05302648.

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 3 Jan 2025.

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