Relapsed and/or Refractory Multiple MyelomaEarly Phase 1NCT05486975
This is an Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Treatment With CT0591CP in Patients With Relapsed and/or Refractory Multiple Myeloma.
A Early Phase 1 study testing CT0591CP 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 CT0591CP in patients with relapsed and/or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- CT0591CP Cells
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 29 Jan 2025
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 75 years, male or female.
- The patients have received at least 3 prior regimens for MM.
- 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, with documented evidence.
- Subjects should have measurable disease per IMWG 2016 criteria serum M-protein or urine M-protein are not measurable.
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- 1） Serum M protein ≥ 5 g / L; 2） 24-hour urinary M-protein ≥ 200 mg; 3） The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria.
- 7. Expected survival > 12 weeks. 8. Eastern Cooperative Oncology Group (ECOG) scores 0 - 1. 9. Subjects should have adequate function in hemostatic and liver and kidney. 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,
- Active hepatitis B; HBV-DNA test must be below the lower limit of measurement.
- Subjects with any uncontrolled active infection (Except for prophylactic treatment).
- 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 autologous BCMA CAR-T therapy
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- Subjects who have had anti-BCMA therapy.
- Subjects who have received allogeneic stem cell transplantation for MM.
- Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF.
- Positive anti-HLA-II antibody specificity test
- Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body.
- Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids.
- Subjects who have Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or primary light chain amyloidosis.
- Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion.
- Subjects allergic to or intolerant of fludarabine, cyclophosphamide, tocilizumab, or allergic to the ingredients (DMSO) of CT0591CP cell preparations; subject with confirmed another serious allergy history.
- Subjects who have any uncontrolled disease conditions within 6 months prior to the signing of inform consent.
- LVEF < 50%
- Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation.
- 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 MM are not eligible if the second malignancy has required treatment within the past 5 years
- 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 ICF 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
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000
Fu chengcheng, Phd, 13962191404, fuzhengzheng@suda.edu.cn
About this study
Official title: Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0591CP Cell 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 CT0591CP in patients with relapsed and/or refractory multiple myeloma.
- Being tested
- CT0591CP Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT0591CP CellsBiological
CT0591CP cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
dose limiting toxicity
Measured: 21-28 days post administration of CT0591CPcells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start10 Aug 2022
- Primary completion29 Jan 2025 (estimated)
- Study completion29 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486975
- Sponsor's protocol ID
- CT0591CP-CG6018
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. 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 CT0591CP Cell in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05486975
- Acronym / sponsor ID
- CT0591CP-CG6018
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 29 Jan 2025 (estimated)
- Study completion
- 29 Jan 2025 (estimated)
- First posted
- 4 Aug 2022 (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 CT0591CP 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)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 75 years, male or female.
- The patients have received at least 3 prior regimens for MM.
- 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, with documented evidence.
Key exclusion criteria (24 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,
- Active hepatitis B; HBV-DNA test must be below the lower limit of measurement.
- Subjects with any uncontrolled active infection (Except for prophylactic treatment).
- 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.
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 |
|---|---|---|
| CT0591CP CellsCT0591CP cells | Biological | – |
Primary outcome
Safety and tolerability
Time frame: 21-28 days post administration of CT0591CPcells
dose limiting toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
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 CT0591CP 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 9 inclusion and 24 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 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengcheng Fu (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?
Safety and tolerability (time frame: 21-28 days post administration of CT0591CPcells). 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 12 Apr 2023.