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Multiple MyelomaPhase 1/2NCT03975907

Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)

A Phase 1/2 study testing CAR-BCMA T Cells in people with Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd. at 23 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or 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?
CAR-BCMA T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
23 sitesChina
Study dates
10 Jun 2019to 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
  • Age ≥ 18 years and ≤ 75 years, male or female
  • The patients have received at least 3 prior lines for MM, (Induction therapy followed by autologous transplantation[ASCT] and maintenance therapy represents one line of therapy, those who have not been treated with ASCT should have documented rationale); For each line of therapy, the patient should have received at least one standard treatment cycle (2016 IMWG) unless the best response to the treatment line is documented as progressive diseases (PD)
  • The patients should have received treatment with at least one proteasome inhibitor AND one immunomodulatory drug, and have ever been relapsed or deteriorated after treatment with at least one regimen consisting of above-mentioned medications (combination or single use)；
  • Patient should be relapsed within 12 months after the last line of therapy, or disease progressed within 60 days after last line of therapy (IMWG criteria 2016), with documented evidence.
  • The patients should have measurable disease based on at least one of the following parameters：
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  • Serum M-protein ≥ 10 g/L;
  • Urine M-protein ≥ 200 mg/24 hrs;
  • For those whose Serum or Urine M- protein dose not meed the measurable criteria but the light chain type, serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
  • Estimated life expectancy > 12 weeks
  • ECOG performance score 0-1；
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis
  • Patients should maintain adequate organ function
  • Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion
  • Men who actively have intercourse with child-bearing potential women must be willing to use effective and reliable method of contraception for at least 1 year after T cell infusion

Who cannot join

  • Pregnant or lactating women；
  • Positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema Pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV e antigen (HBeAg), HBV e antibody, hepatitis B core antibody, HBV DNA;
  • Patients with any uncontrolled active infection including but not limited to active tuberculosis.
  • Patients with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss, neuropathy and other events that the treating physician can determine to be tolerable.
  • Patients who have ever had any CAR T cell therapy；
  • Patients who have ever had anti-BCMA therapy；
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  • Patients have received allogeneic stem cell transplantation for treating multiple myeloma;
  • Patients have received autologous stem cell transplantation less than 12 weeks before leukapheresis；
  • Patients have received any anti-cancer treatment within 14 days before leukapheresis including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, targeted therapies, epigenetic therapy or experimental drug therapy. If the field of radiation covers ≤ 5% of the bone marrow, the subjects are eligible to participate in the study regardless of the radiotherapy end date；
  • Patients have received ≥ 5 mg prednisone daily or other equivalent dose of steroids within 14 days before leukapheresis or lymphodepletion；
  • Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or AL amyloidosis；
  • Patients have been administered live attenuated vaccine 4 weeks before leukapheresis or lymphodepletion
  • Patients allergic to component of study treatment.
  • Patients have any of the condition as following within 6 months of ICF sign-off: New York Heart Association (NYHA) stage III or IV congestive heart failure, angina pectoris, myocardial infarction, coronary artery bypass graft, stroke (excluding lacunar stroke), history of clinically significant arrhythmia including but not limited to ventricular arrhythmia, significant QT interval prolongation, uncontrolled blood pressure as defined as systolic > 160 mmHg, diastolic > 100 mmHg, uncontrolled diabetes mellitus, pulmonary thrombolism, other conditions that investigators believe that participating in this clinical trial may endanger the health of the patients
  • Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy
  • patients are oxygen dependent as defined by the blood oxygen saturation (finger oxygen detection method) can be maintained > 95% only by oxygen inhalation before leukapheresis
  • Patients with second malignancies in addition to MM are not eligible if the second malignancy has required treatment within the past 5 years or is not in complete remission. There are two exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal cell skin carcinoma
  • Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease). Patients with history of spinal cord compression from MM are eligible provided spinal cord compression has been treated with surgery or radiation at least 28 days prior to study entry
  • Patients are unable or unwilling to comply with the requirements of clinical trial
  • Patients have received major surgery 2 weeks prior to leukapheresis or 4 weeks prior to lymphodepletion and after the study treatment (excluding cataract and other local anesthesia)
  • Patients are relatives to investigator or his/her staff, or those who may have an interest in the investigator and/or his/her staff.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Beijing Chaoyang hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Boren Hospital

    Beijing

  • Beijing Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Centre

    Guangzhou, Guangdong

  • The first Affiliated Hospital, College of medicine, Zhejiang University

    Hanzhou, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • Tongji Hospital of Tongji University

    Shanghai

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The 2nd People's Hospital of Shenzhen

    Shenzhen, Guangdong

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University General Hospital

    Tianjin

  • The first Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: Open Label, Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-BCMA Chimeric Antibody Receptor Autologous T Cell （CAR T）in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)

This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or refractory multiple myeloma.

Read the detailed description

The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to Detailed Description: verify the efficacy and safety of the dose proposed.

Being tested
CAR-BCMA T Cells
Keywords
multiple myeloma, car-T
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CAR-BCMA T CellsBiological

    The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.

Study groups in NCT03975907
Study groupRoleWhat they receive
CAR-BCMA T CellsExperimentalPhase I: The subjects are enrolled into 2 dose level cohorts in sequence. Phase II: Single arm
Receives: Biological: CAR-BCMA T Cells

What is being measured

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

  1. Phase 1, Safety and tolerability: dose limiting toxicity

    dose limiting toxicity

    Measured: 28days post administration of CAR-T-cells

  2. Phase 2, efficacy of CT053 CAR-BCMA T cells: overall response rate

    overall response rate (ORR)=（sCR+CR+VGPR+PR)

    Measured: 3 months post administration of CAR-T-cells

Secondary outcomes (19)

  1. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    Minimal residual disease (MRD) negativity

    Measured: 3 months post administration of CAR-T-cells

  2. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    TTR TIme to Response

    Measured: 3 months post administration of CAR-T-cells

  3. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    Complete Response (CR) /stringent Complete Response (sCR)

    Measured: 3 months post administration of CAR-T-cells

  4. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    ≥Very Good Partial Response (VGPR), including VGPR, CR, sCR

    Measured: 3 months post administration of CAR-T-cells

  5. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    ORR at Wk12

    Measured: 3 months post administration of CAR-T-cells

  6. Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

    CBR, clinical benefit rate

    Measured: 3 months post administration of CAR-T-cells

  7. Safety and tolerability of CAR-BCMA T cell therapy

    AE\&SAE

    Measured: through 24 months post administration of CAR-T-cells

  8. Pharmacokinetics (the cell persistence duration in peripheral blood)

    Copy numbers of CAR-BCMA gene in peripheral blood

    Measured: through 24 months post administration of CAR-T-cells

  9. Pharmacokinetics (the cell persistence duration in peripheral blood)

    Number of CAR positive cells in peripheral blood

    Measured: through 24 months post administration of CAR-T-cells

  10. Safety and tolerability of CAR-BCMA T cell therapy

    positivity of ADA (Anti-CAR-T antibody)

    Measured: through 24 months post administration of CAR-T-cells

  11. Efficacy endpoint of CAR-BCMA T cells after infusion

    Overal response rate (ORR)

    Measured: through 24 months post administration of CAR-T-cells

  12. Efficacy endpoint of CAR-BCMA T cells after infusion

    Complete Response (CR) /stringent Complete Response (sCR)

    Measured: through 24 months post administration of CAR-T-cells

  13. Efficacy endpoint of CAR-BCMA T cells after infusion

    ≥Very Good Partial Response (VGPR), including VGPR, CR, sCR

    Measured: through 24 months post administration of CAR-T-cells

  14. Efficacy endpoint of CAR-BCMA T cells after infusion

    Duration of Response (DOR)

    Measured: through 24 months post administration of CAR-T-cells

  15. Efficacy endpoint of CAR-BCMA T cells after infusion

    Clinical Benefit Rate (CBR)

    Measured: through 24 months post administration of CAR-T-cells

  16. Efficacy endpoint of CAR-BCMA T cells after infusion

    Time to Response (TTR)

    Measured: through 24 months post administration of CAR-T-cells

  17. Efficacy endpoint of CAR-BCMA T cells after infusion

    Minimal residual disease (MRD) negativity

    Measured: through 24 months post administration of CAR-T-cells

  18. Efficacy endpoint of CAR-BCMA T cells after infusion

    Progression Free Survival (PFS)

    Measured: through 24 months post administration of CAR-T-cells

  19. Efficacy endpoint of CAR-BCMA T cells after infusion

    Overall Survival (OS)

    Measured: through 24 months post administration of CAR-T-cells

Timeline

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

  1. First posted5 Jun 2019
  2. Study start10 Jun 2019
  3. Primary completion31 Dec 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
Not applicable
Intervention model
Single group
Model description
Phase I is an open-label, dose escalation study and 2 cohorts to evaluate the safety and tolerability of treatment with CT053 and to determine maximum tolerable dose (MTD) and the Recommended Phase 2 Dose (RP2D) for CT053. Phase 2 is a single-arm, open, multi-center study, to evaluate the efficacy and safety of CAR-BCMA T cells (CT053) in subjects with RR/MM.
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975907
Sponsor's protocol ID
CT053-MM-01
Status last verified
Mar 2024
First submitted
30 May 2019
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fu C, Chen W, Cai Z, Yan L, Wang H, Shang J, Wu Y, Yan S, Gao W, Shi X, Han X, Tang F, Zheng G, Wen Y, Meng X, Yuan D, Wang H, Li Z. Long-term follow-up of zevor-cel in patients with relapsed/refractory multiple myeloma. Blood Adv. 2026 Jan 27;10(2):468-478. doi: 10.1182/bloodadvances.2025017365.

    PubMed 41160798

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-BCMA T Cells in people with Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd. at 23 sites 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 15 inclusion and 21 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites 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?

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?

Phase 1, Safety and tolerability: dose limiting toxicity (time frame: 28days post administration of CAR-T-cells). 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 NCT03975907, 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 12 Mar 2024.

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