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Plasma Cell LeukemiaEarly Phase 1NCT06988059

A Study of CT0596 in Plasma Cell Leukemia

A Early Phase 1 study testing CAR-T cells Infusion chimeric antigen receptor T cells in people with Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Leukemia
What is being tested?
CAR-T cells Infusion chimeric antigen receptor T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
25 Jun 2025to 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

  • 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;
  • PCL after inductive treatment or R/R pPCL.
  • Patients must have measurable disease。
  • Expected survival > 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;
  • Patients should have good organ function。
  • 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;
  • 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;
  • 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
  • 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 or five half-lives before preconditioning
  • 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;
  • 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);
  • 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 with secondary plasma cell leukemia, 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 in addition to MM 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;
  • The patient is unable or unwilling to comply with protocol, or there are other reasons for being unsuitable to participate in this clinical study evaluated by investigators.

Trial locations and contacts

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

China1 site, 1 recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

    Gang An, PhD, 86-022-23909171, angang@ihcams.ac.cn

    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 Plasma Cell Leukemia

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

Read the detailed description

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

Being tested
CAR-T cells Infusion chimeric antigen receptor T cells
Keywords
Plasma Cell Leukemia, CAR-T cells
Medical subject headings
Leukemia, Plasma Cell

What participants receive

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

  • CAR-T cells Infusion chimeric antigen receptor T cellsDrug

    CAR-T cells Infusion

Study groups in NCT06988059
Study groupRoleWhat they receive
CAR-T cells Infusion chimeric antigen receptor T cellsExperimentalNot described
Receives: Drug: CAR-T cells Infusion chimeric antigen receptor T cells

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 infusion 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 infusion 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 infusion 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 posted23 May 2025
  2. Study start25 Jun 2025
  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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988059
Sponsor's protocol ID
IIT2025050
Status last verified
Jul 2025
First submitted
16 May 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CAR-T cells Infusion chimeric antigen receptor T cells in people with Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 inclusion and 19 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 1 Aug 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?

Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT06988059.

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 1 Aug 2025.

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