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Relapsed/Refractory Multiple MyelomaEarly Phase 1NCT06718270

a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia

A Early Phase 1 study testing CAR-T cells Infusion in people with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia, run by Shanghai Changzheng Hospital 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
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Trial summary

This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CAR-T cells Infusion
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
11 Dec 2024to 31 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be enrolled:
  • Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
  • Age ≥ 18 years;
  • Patients with R/RMM who have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor and at least 1 immunomodulator (IMiD). Patients with RRpPCL had received at least 1 prior line of therapy. Number of lines of therapy was defined according to the guidelines provided in Rajkuma[1]r 2015 . Patients must have received at least 1 complete cycle of therapy for each line of therapy.
  • According to multiple myeloma IMWG 2016 and plasma cell leukemia IMWG 2013, patients must have progressive disease following or during the last treatment.
  • Patients must have measurable disease based on at least one of the following parameters:
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  • Expected survival > 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;
  • Patients should meet the following test results
  • Female patients of childbearing potential must have a negative pregnancy test at screening and prior to receiving lymphodepletion therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study ;Male patients are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited within 1 year following study treatment infusion for all male patients during the study.

Who cannot join

  • Pregnant or lactating women;
  • Patient has any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the patient to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Patients seropositive for HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing;
  • Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment);
  • Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;
  • Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent;
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  • Have received treatment for the disease within 14 days before informed consent
  • Have received cell therapy within 28 days before informed consent.
  • Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
  • Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent;
  • Allergic or intolerant to lymphodepletion, tocilizumab, or allergic to components (DMSO) in CT0596 CART cell infusion preparation; or previous history of other serious allergies such as anaphylactic shock;
  • Patients Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at Screening;
  • Patients with any of the following cardiac conditions within 6 months prior to screening:
  • Patients who require supplemental oxygen to maintain oxygen saturation > 92%; or Patients with known or suspected COPD who have Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal on spirometry;
  • Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy;
  • Patients with second primary malignancies are not eligible if the second primary malignancy has required treatment within the past 2 years or is not in complete remission. Exceptions include the following that have been successfully treated - nonmetastatic basal cell or squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma-in-situ of breast or cervix, non-muscle invasive bladder cancer
  • Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases;
  • Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract)

Trial locations and contacts

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

Juan Du, Ph D contact

15800706091

juan_du@live.com

China1 site, 1 recruiting

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200000

    Juan Du, PhD, 15800706091, juan_du@live.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia

This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL

Read the detailed description

This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL.

During the trial, dose increases or decreases or dose expansion may be performed using i3+3 principle based on the safety and ,tolerability and PK data of the patients.

All Patients will undergo a DLT assessment period which is defined as the first 28 days starting from the day of CT0596 infusion. A patient is evaluable for DLTs if the patient received the planned CT0596 dose and either completed the 28 days of DLT evaluation period after CT0596 infusion or experienced a DLT. Enrolled patients who are not evaluable for DLTs during dose escalation may be replaced. Any Patients who are not DLT evaluable will still be followed for safety and efficacy per the SOA.

Being tested
CAR-T cells Infusion
Keywords
Relapsed/Refractory Multiple Myeloma, Relapsed or Refractory Plasma Cell Leukemia, CAR-T
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Recurrence

What participants receive

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

  • CAR-T cells InfusionDrug

    chimeric antigen receptor T cells

Study groups in NCT06718270
Study groupRoleWhat they receive
CAR-T cells InfusionExperimentalchimeric antigen receptor T cells
Receives: Drug: CAR-T cells Infusion

What is being measured

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

  1. Adverse Events (AE) after CT0596 infusion

    An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

    Measured: 12 months after CT0596 infusion

  2. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion

    Measured: 12 months after CT0596 infusion

Secondary outcomes (12)

  1. Overall response rate (ORR) as assessed by the investigator

    Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria

    Measured: 12 months after CT0596 infusion

  2. Complete response/stringent complete response (CR/sCR) rate

    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: 12 months after CT0596 infusion

  3. Rate of very good partial response (VGPR) and above

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

    Measured: 12 months after CT0596 infusion

  4. 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: 12 months after CT0596 infusion

  5. 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: 12 months after CT0596 infusion

  6. Time to response (TTR)

    TTR defined as the time from the date of apheresis to the date of initial assessment of PR or better according to IMWG2016 criteria

    Measured: 12 months after CT0596 infusion

  7. 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: 12 months after CT0596 infusion

  8. Peak value of CART cells

    Time to peak expansion and peak expansion in plasma after infusion of CT0596 cells

    Measured: 12 months after CT0596 infusion

  9. Overall survival (OS)

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

    Measured: 12 months after CT0596 infusion

  10. Cytokines in the peripheral blood after CT0596 infusion

    Serum concentrations of interleukin (IL)-6 after CT0596 infusion

    Measured: 12 months after CT0596 infusion

  11. Area under the plasma concentration versus time curve (AUC) of CART cells

    Area under the plasma concentration versus time curve (AUC) in plasma after infusion of CT0596 cells

    Measured: 12 months after CT0596 infusion

  12. In vivo persistence of CART cells

    CART cells duration in plasma after infusion of CT0596 cells

    Measured: 12 months after CT0596 infusion

Timeline

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

  1. First posted5 Dec 2024
  2. Study start11 Dec 2024
  3. Primary completion3 Jan 2027 (estimated)
  4. Study completion31 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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06718270
Sponsor's protocol ID
CT0596-CG6022_01
Status last verified
Nov 2024
First submitted
24 Nov 2024
Last updated
12 Dec 2024
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 CAR-T cells Infusion in people with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory 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 10 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: looking for participants now, as of the sponsor's last update on 12 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 Juan Du, Ph D (15800706091, juan_du@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) after CT0596 infusion (time frame: 12 months after CT0596 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 NCT06718270.

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 Dec 2024.

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