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Multiple MyelomaEarly Phase 1NCT05838131

Study of CT071 Injection in RRMM or PPCL

A Early Phase 1 study testing Experimental: CAR-T cells Infusion in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by Shanghai Changzheng Hospital 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

A Clinical Trial to Explore the Safety and Efficacy of CT071 injection in Patients with Relapsed/Refractory Multiple Myeloma or Primary Plasma Cell Leukemia Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Experimental: CAR-T cells Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
28 Apr 2023to Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in the clinical trial; fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
  • Age ≥ 18 years, male or female;
  • Patients with multiple myeloma who have received at least three lines therapy for multiple myeloma (requires relapse, progression, non-response after treatment with at least 1 proteasome inhibitor and at least 1 immunomodulator.
  • Patients with primary plasma cell leukemia progressed after treatment with at least 1 regimen;
  • Progressive disease at the time of enrollment according to the IMWG consensus for myeloma or plasma cell leukemia;
  • Have any of the following evaluable conditions:
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  • Serum M-protein ≥ 5 g/L;
  • 24-hour urine M-protein ≥ 200 mg;
  • Abnormal serum free light chain (sFLC) ratio and affected FLC ≥ 100 mg/L in subjects with multiple myeloma who did not meet evaluable criteria for either serum or urine M-protein levels;
  • Circulating plasma cells ≥ 5% (PCL subjects only);
  • Estimated survival > 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) score 0-2;
  • Subjects had adequate organ function.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening, be willing to use a highly effective and reliable method of contraception within 1 year after receiving the trial treatment, and absolutely prohibit egg donation during the trial and within 1 year after receiving the trial treatment;
  • Male subjects, if sexually active with a female of childbearing potential, are willing to use a highly effective and reliable method of contraception for 1 year after receiving trial treatment. All male subjects are absolutely prohibited from donating sperm during the trial and for 1 year after receiving the trial treatment.

Who cannot join

  • Pregnant or lactating females;
  • Patients with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disease or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
  • Patients with other incurable malignant tumors within 5 years or at the same time, except for those with very low degree of malignancy;
  • Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, inflammatory bowel disease and other patients requiring long-term immunosuppressive therapy;
  • Received allogeneic stem cell transplantation within two years prior to screening;
  • Received autologous stem cell transplantation within 12 weeks prior to screening, or plan to receive autologous stem cell transplantation during the trial;
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  • Any uncontrolled disease or disorder with important clinical significance investigator considered not applicable for the study;
  • Patients who had any uncontrolled active infection (defined as the presence of persistent signs or symptoms associated with infection that did not improve despite appropriate antiinfective treatment) or who required intravenous antiinfective agents (except for prophylactic treatment) within 4 weeks before apheresis. If there is clinical indications, investigators should consider screening EBV, CMV, and other related pathogenic microorganisms;
  • Major surgery within 2 weeks prior to screening, or planning to undergo major surgery within 4 weeks after trial treatment (excluding cataract and other surgery under local anesthesia);
  • Received treatment for the disease under study within 2 weeks prior to apheresis(or within five half-lives of the drug, whichever is shorter), including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy, epigenetic therapy, etc.; Received anti-PD-1/PD-L1 monoclonal antibody or other investigational drug/invasive medical device within 4 weeksprior to apheresis;
  • Vaccination with live attenuated vaccine or mRNA vaccine within 8 weeks and inactivated vaccine within 4 weeks before screening;
  • Patients who are allergic or intolerant to CLD drugs, tocilizumab, or allergic to the ingredients of CT071 cell infusion preparation (DMSO); Or previous history of other severe allergies, such as anaphylactic shock;
  • Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis C virus (HCV) RNA, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA;
  • The toxicities caused by the previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Oxygen saturation < 92% at room air;
  • Received glucocorticoids within 7 days prior to apheresis, with the exception of inhaled glucocorticoids and physiologic replacement doses;
  • Other conditions considered inappropriate for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Changzheng Hospital

    Shanghai

Other trials in China

About this study

Official title: A Clinical Trial to Explore the Safety and Efficacy of CT071 Injection in Patients With Relapsed/Refractory Multiple Myeloma or Primary Plasma Cell Leukemia

A Clinical Trial to Explore the Safety and Efficacy of CT071 injection in Patients with Relapsed/Refractory Multiple Myeloma or Primary Plasma Cell Leukemia

Read the detailed description

This trial is a single-arm, open-label, dose-finding, first-in-human clinical trial. The main aim of this study is to preliminarily evaluate the safety and tolerability of CT071 after infusion, and explore the dose range of CT071 in patients with relapsed/refractory multiple myeloma or primary plasma cell leukemia, so as to determine the possible recommended therapeutic dose (RD).

Being tested
Experimental: CAR-T cells Infusion
Keywords
multiple myeloma, primary plasma cell leukemia, 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.

  • Experimental: CAR-T cells InfusionDrug

    Also called Single Group Assignment

    Biological:

    chimeric antigen receptor T cells

Study groups in NCT05838131
Study groupRoleWhat they receive
CAR-T cells InfusionExperimentalBiological: CART cells chimeric antigen receptor T cells
Receives: Drug: Experimental: CAR-T cells Infusion

What is being measured

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

  1. DLT after CT071 infusion

    Evaluate DLT and adverse events after CT071 infusion

    Measured: Assessed from the date of first dose of study treatment until 21~28 days

  2. AE of Neurotoxicity and cytokine release syndrome after CT071 infusion

    Cytokine release syndrome（CRS）should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading，higher scores mean a worse outcome.

    Measured: From first dose of study drug adminisration to end of treatment (up to 12 months)

  3. Adverse Events (AE) after CT071 infusion

    An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS).

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

Secondary outcomes (10)

  1. Level of CAR-T Cell Expansion (proliferation), and Persistence

    Levels of cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.

    Measured: From first dose of study drug administration to 26 weeks

  2. Cytokines in the peripheral blood after CT071 infusion

    Serum concentrations of interleukin (IL)-2, IL-6，IL-8，IL-10，interferon-gamma (IFN-γ), and TNF-α after CT071 infusion

    Measured: From first dose of study drug administration to 4 weeks

  3. Preliminary evaluation of immunogenicity

    ADA positive rate

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  4. Overall response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria after CT071 infusion

    ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  5. Rate of very good partial response (VGPR) and above, complete response/stringent complete response (CR/sCR);

    Rate of very good partial response (VGPR) and above defined as proportion of patients achieving VGPR or better based on IMWG defined response criteria;

    Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria.

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  6. Duration of response (DOR)

    DOR is defined as the time from first achieving PR or better to confirmed disease progression or death from any cause.

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  7. Minimal residual disease (MRD) negative rate;

    Minimal residual disease (MRD) negative rate is defined as the proportion of patients with VGPR or better who achieved 10-5 sensitivity of nucleated cell.

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  8. Time to response (TTR)

    TTR defined as the time from the date of apheresis to the date of initial assessment of PR or better in patients with a best response assessment of partial response or better according to IMWG2016 criteria.

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  9. Progression-free survival (PFS)

    PFS defined as the time from the date of apheresis of the subject to the first assessment of confirmed disease progression or death from any cause according to IMWG2016 criteria, whichever occurs first.

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

  10. Overall survival (OS)

    OS defined as the time from the date of apheresis of the subject to death from any cause.

    Measured: From first dose of study drug administration to death

Timeline

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

  1. First posted1 May 2023
  2. Study start28 Apr 2023
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838131
Sponsor's protocol ID
CT071-CG7001
Status last verified
Jan 2025
First submitted
3 Apr 2023
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jin L, Gu S, Ruan Q, Lu J, Qiang W, He H, Fan X, Liu J, Guo P, Meng X, Rajakumaraswamy N, Chen D, Li Z, Du J. GPRC5D-targeted CAR T-cell therapy (CT071) in patients with relapsed or refractory multiple myeloma: a first-in-human, single-centre, single-arm, phase 1 trial. Lancet Haematol. 2025 Oct;12(10):e798-e807. doi: 10.1016/S2352-3026(25)00176-0.

    PubMed 41062204

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Experimental: CAR-T cells Infusion in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by Shanghai Changzheng 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 15 inclusion and 18 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 7 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?

DLT after CT071 infusion (time frame: Assessed from the date of first dose of study treatment until 21~28 days). The study lists 3 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 NCT05838131, 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 7 Jan 2025.

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