Relapsed/Refractory Plasma Cell LeukemiaEarly Phase 1NCT06730256
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 chimeric antigen receptor T cells in people with Relapsed/Refractory Plasma Cell Leukemia and Relapsed/Refractory Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Plasma Cell Leukemia, Relapsed/Refractory Multiple Myeloma
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 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
- 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:
Show all 10Show fewer
- 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
- 1. Pregnant or lactating women; 2. 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 3. 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; 4. Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment); 5. 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; 6. Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent; 7. Have received treatment for the disease within 14 days before informed consent 8. Have received cell therapy within 28 days before informed consent. 9. Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids; 10. Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent; 11. 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; 12. Patients with secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at Screening; 13. Patients with any of the following cardiac conditions within 6 months prior to screening: 14. 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; 15. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy; 16. 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 17. Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases; 18. 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.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Chengcheng Fu, Ph D, 13962191404
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
A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia.
- Being tested
- CAR-T cells Infusion chimeric antigen receptor T cells
- Keywords
- Relapsed/Refractory Multiple Myeloma, Relapsed or Refractory Plasma Cell Leukemia, CAR-T
- Medical subject headings
- Leukemia, Plasma Cell, Multiple Myeloma, Recurrence
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 chimeric antigen receptor T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells Infusion chimeric antigen receptor T cells | Experimental | Drug: CAR-T cells Infusion chimeric antigen receptor T cells 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.
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]
Maximum tolerated dose and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion
Measured: 12 months after CT0596 infusion
Secondary outcomes (10)
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
Complete response/stringent complete response (CR/sCR) rate
Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving complete response or better based on International Myeloma Working Group( IMWG) defined response criteria.
Measured: 12 months after CT0596 infusion
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 International Myeloma Working Group(IMWG) defined response criteria
Measured: 12 months after CT0596 infusion
Duration of response (DOR)
Duration of response (DOR) is defined as the time from first achievingpartial response( PR )or better to confirmed disease progression or death from any cause
Measured: 12 months after CT0596 infusion
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
Time to response (TTR)
Time to response(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
Progression-free survival (PFS)
Progression-free survival(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 International Myeloma Working Group( IMWG)2016 criteria, whichever occurs first.
Measured: 12 months after CT0596 infusion
Test Copy number of CAR
Evaluate cellular pharmacokinetics of CT0596
Measured: 12 months after CT0596 infusion]
Overall survival (OS)
Overall survival(OS) defined as the time from the date of apheresis of the subject to death from any cause
Measured: 12 months after CT0596 infusion
Cytokines in the peripheral blood after CT0596 infusion
Serum concentrations of interleukin (IL)-6 after CT0596 infusion
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.
- First posted12 Dec 2024
- Study start23 Jul 2025
- Primary completion3 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Plasma Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730256
- Sponsor's protocol ID
- CT0596-CG6022_02
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06730256
- Acronym / sponsor ID
- CT0596-CG6022_02
- Keywords
- Relapsed/Refractory Multiple Myeloma, Relapsed or Refractory Plasma Cell Leukemia, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells Infusion chimeric antigen receptor T cells | Experimental | Drug: CAR-T cells Infusion chimeric antigen receptor T cellsDrug: CAR-T cells Infusion chimeric antigen receptor T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must meet all of the following criteria to be enrolled:
Key exclusion criteria (1 listed)
- 1. Pregnant or lactating women; 2. 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 3. 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; 4. Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment); 5. 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; 6. Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent; 7. Have received treatment for the disease within 14 days before informed consent 8. Have received cell therapy within 28 days before informed consent. 9. Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids; 10. Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent; 11. 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; 12. Patients with secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at Screening; 13. Patients with any of the following cardiac conditions within 6 months prior to screening: 14. 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; 15. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy; 16. 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 17. Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases; 18. 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T cells Infusion chimeric antigen receptor T cellsCAR-T cells Infusion chimeric antigen receptor T cells | Drug | CAR-T cells Infusion chimeric antigen receptor T cells |
Primary outcome
Adverse Events (AE) after CT0596 infusion
Time frame: 12 months after CT0596 infusion]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Maximum tolerated dose and/or dose range
Time frame: 12 months after CT0596 infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion
10 secondary outcomes
Overall response rate (ORR) as assessed by the investigator
Time frame: 12 months after CT0596 infusion
Complete response/stringent complete response (CR/sCR) rate
Time frame: 12 months after CT0596 infusion
Rate of very good partial response (VGPR) and above
Time frame: 12 months after CT0596 infusion
Duration of response (DOR)
Time frame: 12 months after CT0596 infusion
Minimal residual disease (MRD) negative rate
Time frame: 12 months after CT0596 infusion
Time to response (TTR)
Time frame: 12 months after CT0596 infusion
Progression-free survival (PFS)
Time frame: 12 months after CT0596 infusion
Test Copy number of CAR
Time frame: 12 months after CT0596 infusion]
Overall survival (OS)
Time frame: 12 months after CT0596 infusion
Cytokines in the peripheral blood after CT0596 infusion
Time frame: 12 months after CT0596 infusion]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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 Relapsed/Refractory Plasma Cell Leukemia and Relapsed/Refractory Multiple Myeloma, run by The First Affiliated Hospital of Soochow University 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 1 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 Oct 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?
Contact Chengcheng Fu, Ph D (13962191404, fuzhengzheng@suda.edu.cn), 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?
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 Oct 2025.