Relapsed and/or Refractory Multiple MyelomaNCT05066022
A Study to Access the Safety and Efficacy of CT0590 in Patients With Relapsed and/or Refractory Multiple Myeloma
A study testing CT0590 CAR T Cells in people with Relapsed and/or Refractory Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0590 CAR T in patients with relapsed and/or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- CT0590 CAR 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
- 28 Oct 2021to 29 Jul 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients and legally acceptable representative must have voluntarily signed Informed Consent Form and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 70 years, male or female.
- The patients have received at least 3 prior regimen for multiple myeloma.
- Subjects should have received treatment with at least one proteasome inhibitor and one immunomodulatory drug (IMiD; and have been stable disease, relapsed or progressed after treatment with at least one regimen consisting of above-mentioned medications.
- Subjects should have relapsed within 12 months after the last line of therapy, or not achieved at least minimal response (MR) or disease has progressed within 60 days after last line of therapy (IMWG criteria 2016), with documented evidence.
- Subjects should have measurable disease per IMWG 2016 criteria.
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- Expected survival > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) scores 0 - 1.
- Subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments):
- 1) Complete blood count (CBC) results: absolute neutrophil count（ANC） ≥ 1.0 × 109/L, platelet count ≥ 75 × 109/L (if the proportion of plasma cells in the bone marrow is > 50%, subjects with platelets ≥ 50 × 109/L will be eligible), Hb ≥ 70 g/L.
- 2) Blood biochemistry: creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN)，aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN.
- 10. Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after T cell infusion. All female subjects are prohibited from egg donation within 1 year after T cell infusion.
- 11. Men must be willing to use an effective and reliable method of contraception for at least 1 year after T cell infusion if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after T cell infusion.
Who cannot join
- Pregnant or lactating women.
- Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA.
- Subjcets with any uncontrolled active infection, including but not limited to active tuberculosis (TB) (judged by investigator).
- Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
- Subjects who have received CAR T therapy for any targets.
- Subjects who have had anti-B Cell Maturation Antigen（BCMA） therapy.
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- Subjects who have received allogeneic stem cell transplantation for multiple myeloma.
- Subjects who have received autologous stem cell transplantation less than 12 weeks before leukapheresis.
- Subjects who have received any anti-myeloma treatment 14 days before leukapheresis, including but not limited to cytotoxic therapy, proteasome inhibitor, immunomodulator, target therapy, monoclonal antibodies, radiotherapy, epigenetic therapy or investigational drug, or the use of invasive investigational medical device. 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.
- Subjects who have received ≥ 15 mg prednisone daily or other equivalent dose of steroids within 7 days before leukapheresis, except inhaled steroids.
- Subjects who have plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or primary light chain amyloidosis.
- Subjects who have been received a live attenuated vaccine 4 weeks before leukapheresis.
- Subjects allergic to or intolerant of fludarabine, cyclophosphamide, tocilizumab, or allergic to the ingredients (DMSO) of CT0590 T cell preparations; subject with confirmed another serious allergy history.
- Subjects who have any of the following conditions within 6 months prior to the signing of inform consent: uncontrolled congestive heart failure (New York Heart Association (NYHA) stage III or IV), angina, myocardial infarction, stroke (except lacunar infarct), coronary artery bypass graft, clinically meaningful (judged by investigator) arrhythmia (including but not limited to ventricular arrhythmia, significant QT interval prolongation (Bazett's formula corrected QT,corrected QT ≥ 500 ms, judged by investigator), uncontrolled blood pressure as defined as systolic > 160 mmHg, diastolic >100 mmHg, uncontrolled diabetes as defined as HbA1c >8% after treatment, pulmonary embolism, or other conditions that the investigator believe that participating in this clinical trial may endanger the health of the subjects.
- Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation before leukapheresis.
- Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy.
- Subjects with second malignancies in addition to multiple myeloma are not eligible if the second malignancy has required treatment within the past 5 years, with the exception of low grade malignancies.
- Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement.
- Subjects who are unable or unwilling to comply with the requirements of clinical trial or other reasons that are not suitable for participating in the clinical trial.
- Subjects who have received major surgery 2 weeks prior to leukapheresis or plan to receive major surgery within 4 weeks after cell infusion (excluding cataract and other local anesthesia).
- Subjects who are related to investigator or study personnel, or with possible conflict of interest with the investigator or study personnel.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
chengcheng Fu, PhD, 0512-67781856, fuzhengzheng@suda.edu.cn
About this study
Official title: Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0590 Chimeric Antigen Receptor T Cell （CAR T）in Patients With Relapsed and/or Refractory Multiple Myeloma
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0590 CAR T in patients with relapsed and/or refractory multiple myeloma.
- Being tested
- CT0590 CAR T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT0590 CAR T CellsBiological
Dose-escalated CAR T cells infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CT0590 CAR T cells | Experimental | Dose-escalated CAR T cells infusion Receives: Biological: CT0590 CAR T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicity
The incidence of dose-limiting toxicity（predetermined in protocol）and explore the appropriate dose
Measured: 28 days 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.
- First posted4 Oct 2021
- Study start28 Oct 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion29 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CAR T
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, Fu chengcheng PhD, The First Affiliated Hospital of Soochow University
- Investigators
- Chengcheng Fu, PhD, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066022
- Sponsor's protocol ID
- CT0590-CG6012
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin S, Liao Z, Yan S, Yan L, Yao W, Shang J, Tang F, Zhu Z, Wu D, Rajakumaraswamy N, Luo Y, Yuan D, Jiang H, Li Z, Fu C. A novel triple-knockout allogeneic BCMA CAR T-cell therapy (CT0590) for multiple myeloma: preclinical and phase 1 study. Blood. 2026 Sep 3;148(10):1251-1262. doi: 10.1182/blood.2025032112.
PubMed 42275247
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0590 Chimeric Antigen Receptor T Cell （CAR T）in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05066022
- Acronym / sponsor ID
- CT0590-CG6012
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 28 Oct 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 29 Jul 2024 (estimated)
- First posted
- 4 Oct 2021 (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.
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0590 CAR T in patients with relapsed and/or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CAR T
| Arm | Type | Receives |
|---|---|---|
| Experimental: CT0590 CAR T cells | Experimental | Biological: CT0590 CAR T CellsDose-escalated CAR T cells infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients and legally acceptable representative must have voluntarily signed Informed Consent Form and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 70 years, male or female.
- The patients have received at least 3 prior regimen for multiple myeloma.
- Subjects should have received treatment with at least one proteasome inhibitor and one immunomodulatory drug (IMiD; and have been stable disease, relapsed or progressed after treatment with at least one regimen consisting of above-mentioned medications.
- Subjects should have relapsed within 12 months after the last line of therapy, or not achieved at least minimal response (MR) or disease has progressed within 60 days after last line of therapy (IMWG criteria 2016), with documented evidence.
Key exclusion criteria (21 listed)
- Pregnant or lactating women.
- Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA.
- Subjcets with any uncontrolled active infection, including but not limited to active tuberculosis (TB) (judged by investigator).
- Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
- Subjects who have received CAR T therapy for any targets.
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 |
|---|---|---|
| CT0590 CAR T CellsDose-escalated CAR T cells infusion | Biological | Experimental: CT0590 CAR T cells |
Primary outcome
The incidence of dose-limiting toxicity
Time frame: 28 days post administration of CAR-T-cells
The incidence of dose-limiting toxicity（predetermined in protocol）and explore the appropriate dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Derived from this study: PubMed 42275247Jin S, Liao Z, Yan S, Yan L, Yao W, Shang J, Tang F, Zhu Z, Wu D, Rajakumaraswamy N, Luo Y, Yuan D, Jiang H, Li Z, Fu C. A novel triple-knockout allogeneic BCMA CAR T-cell therapy (CT0590) for multiple myeloma: preclinical and phase 1 study. Blood. 2026 Sep 3;148(10):1251-1262. doi: 10.1182/blood.2025032112.
- 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. This study is not recruiting at the moment.
Chengcheng Fu, PhD principal investigator
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT0590 CAR T Cells in people with Relapsed and/or 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 13 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 4 Nov 2021. 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.
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?
Contact chengcheng Fu, PhD (0512-67781856, fuzhengzheng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicity (time frame: 28 days post administration of CAR-T-cells). 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 NCT05066022, 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 4 Nov 2021.