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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study. 2. Age ≥ 18 years and ≤ 75 years, male or female. 3. The patients have received at least 3 prior regimens for MM. 4. 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. 5. 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. 6. Subjects should have measurable disease per IMWG 2016 criteria serum M-protein or urine M-protein are not measurable. 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.

Exclusion Criteria:

1. Pregnant or lactating women. 2. Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, 3. Active hepatitis B; HBV-DNA test must be below the lower limit of measurement. 4. Subjects with any uncontrolled active infection (Except for prophylactic treatment). 5. 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. 6. Subjects who have received autologous BCMA CAR-T therapy. 7. Subjects who have had anti-BCMA therapy. 8. Subjects who have received allogeneic stem cell transplantation for MM. 9. Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF. 10. Positive anti-HLA-II antibody specificity test. 11. 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. 12. Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids. 13. Subjects who have Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or primary light chain amyloidosis. 14. Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion. 15. 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. 16. Subjects who have any uncontrolled disease conditions within 6 months prior to the signing of inform consent. 17. LVEF < 50% 18. Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation. 19. Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy. 20. Subjects with second malignancies in addition to MM are not eligible if the second malignancy has required treatment within the past 5 years. 21. Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement. 22. 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. 23. 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). 24. Subjects who are related to investigator or study personnel, or with possible conflict of interest with the investigator or study personnel.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05486975
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The First Affiliated Hospital of Soochow University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed and/or Refractory Multiple Myeloma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.