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Multiple MyelomaPhase 1/2NCT04714827

Targeting CD19 and BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing KQ-2003 CAR-T cells in people with Multiple Myeloma, run by Shanxi Province Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of KQ-2003 CAR-T cells for the treatment of multiple myeloma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
KQ-2003 CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
22 Jan 2021to 31 Dec 2025
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Agreed to participate in this study and signed informed consent, and willing to finish all the test procedure.
  • Age ≧ 18 years of age, gender not limited;
  • According to IMWG， diagnosis of multiple myeloma patients;
  • ECOG physical score ≤2 points ;
  • Relapsed multiple myeloma: disease progressed after received at least 3 lines treatment (must including the proteasome inhibitors and immune modulators); Refractory multiple myeloma: early treatment has never reached more than MR and curative effect; Or early treatment has reached more than MR and curative effect, but the subsequent treatment process or disease progress within 60 days after the last treatment ;
  • Have a measurable lesions in screening period (conform to one of the following standards: (1) the serum M protein: IgG protein≥10g/L, or IgA M protein ≥5g/L, or IgD M protein ≥5g/L; (2) M protein urine ≥200mg/24h; (3)If M protein in serum or urine cannot be measured,under the condition of the abnormal serum free light chain ratio,serum free light chain immunoglobulin or 100 mg/L;
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  • Test results in screening period: (1) Hb≥60 g/L (7 days before the inspection without blood transfusion),PLT≥ 50 x 10 ^ 9 / L(7 days before the inspection without blood transfusion) ,ALC≥0.3×10^9/L,ANC≥0.75×10^9/L; (2)AST≤3ULN,ALT≤3ULN,TBIL≤2ULN；Ccr≥30 mL/min/1.73 m2;Correction of serum calcium ≤3.1mmol/L（≤12.5mg/dL）; LVEF≥40%； Baseline peripheral blood oxygen saturation ≥95%;
  • Female subjects with fertility ,pregnancy blood test results should be negative in screening period and before remove the lymphocyte ;
  • Expected to survival more than 3 months;

Who cannot join

  • The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive;
  • The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;
  • Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure;
  • In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs;
  • Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;
  • Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included );
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  • Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO ;
  • Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells;
  • The other situations that researchers determined doesn't fit to participate in this study.

Trial locations and contacts

1 site in 1 country.

Liping Su, M.D. contact

13835158122 ext. +86

sulp2005@sohu.com

China1 site, 1 recruiting

  • Hematology Department of ShanXi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Tao Guan, PhD, +8613509717461, 395714554@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety and Effectiveness of CD19-BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma

Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of KQ-2003 CAR-T cells for the treatment of multiple myeloma

Read the detailed description

A non randomized study ,plans to enrollment 24 patients of B cell lymphoma ，divided into low, medium and high dose groups，to evaluate the safety and tolerability of KQ-2003 CAR-T cells immunotherapy in patients with relapsed or refractory B cell lymphoma ，to evaluate the preliminary efficacy and observe PK/PD parameters of KQ-2003 CAR-T cells immunotherapy in patients with relapsed or refractory multiple myeloma .

Being tested
KQ-2003 CAR-T cells
Medical subject headings
Multiple Myeloma

What participants receive

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

  • KQ-2003 CAR-T cellsBiological

    Also called Fluorine dara marina injection, Cyclophosphamide injection, CD19-BCMA CAR-T Cells

    A autologous doping CAR - T cells injection targets with CD19 and BCMA，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion KQ-2003 CAR-T cells .

Study groups in NCT04714827
Study groupRoleWhat they receive
Low Dose GroupExperimentalKQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 1.0×10^6 CAR+T cells/kg.
Receives: Biological: KQ-2003 CAR-T cells
Middle Dose GroupExperimentalKQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 2.5×10^6 CAR+T cells/kg.
Receives: Biological: KQ-2003 CAR-T cells
High Dose GroupExperimentalKQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 5.0×10^6 CAR+T cells/kg.
Receives: Biological: KQ-2003 CAR-T cells
Amplification Dose GroupExperimentalKQ-2003 CAR-T cells injection, infused only once.After determined maximum tolerated dose,15 subjects of amplification dose group will be intravenously infuse with 1.0-5.0×10^6 CAR+Tcells/kg.
Receives: Biological: KQ-2003 CAR-T cells

What is being measured

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

  1. DLT

    Observe wether dose limiting toxicity will happened in dose escalation phase

    Measured: Form infusion CAR-T cells to 28 days after infusion

  2. ORR

    The overall response rate after CAR-T Cells immunotherapy

    Measured: Form infusion CAR-T cells to 2 years after infusion

Secondary outcomes (12)

  1. Incidence of various types of adverse recation

    According to CTCAE 5.0, record the level , type of adverse events, evaluat the correlation of CD19-BCMA CAR-T cells

    Measured: Form infusion CAR-T cells to 2 years after infusion

  2. PFS

    Progression-free surial

    Measured: Form infusion CAR-T cells to 2 years after infusion

  3. DOR

    Duration of Response

    Measured: Form infusion CAR-T cells to 2 years after infusion

  4. OS

    Overall survival

    Measured: Form infusion CAR-T cells to subjects died，assessed up to 60 months

  5. Cmax

    By measuring the CAR - T cells copy number and the positive rate, peak plasma concentration is determined

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  6. Tmax

    The maximum concentration of time

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  7. AUC（0-720d）

    Area under the plasma concentration versus time curve

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  8. Concentration of IL2 level

    The levels of cytokines（IL2 ）in peripheral blood and bone marrow

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  9. Concentration of IL6 level

    The levels of cytokines（ IL6 ）in peripheral blood and bone marrow

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  10. Concentration of IL10 level

    The levels of cytokines（IL10 ）in peripheral blood and bone marrow

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  11. Concentration of TNF-α level

    The levels of cytokines（TNF-α ）in peripheral blood and bone marrow

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24

  12. Concentration of IFN-γ level

    The levels of cytokines（IFN-γ ）in peripheral blood and bone marrow

    Measured: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, 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 posted19 Jan 2021
  2. Study start22 Jan 2021
  3. Primary completion30 Sep 2024 (estimated)
  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
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714827
Sponsor's protocol ID
CAR-T SXZL03
Status last verified
Dec 2023
First submitted
7 Jan 2021
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to Share Clinical Study Report within six months after the study completed

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KQ-2003 CAR-T cells in people with Multiple Myeloma, run by Shanxi Province Cancer 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 9 inclusion and 9 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 29 Dec 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Liping Su, M.D. (13835158122 ext. +86, sulp2005@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Form infusion CAR-T cells to 28 days after infusion). 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 NCT04714827.

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 29 Dec 2023.

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