CT0594CP CAR-T Cells in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Study Details
Study Description
Brief Summary
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CT0594CP CAR-T Cells[BCMA-UCAR-T(CT0594) and CD9-UCAR-T(CT7590)] CT0594CP |
Biological: CT0594CP
Cell injection
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerabilitydose limiting toxicity [21-28 days]
Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
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Age ≥ 18 years and ≤ 75 years, male or female.
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The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past.
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According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state
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Subjects should have measurable disease. 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.
4） Circulating plasma cells ≥2% 6. Expected survival > 12 weeks. 7. Eastern Cooperative Oncology Group (ECOG) scores 0-1. 8. Subjects should have adequate function in hemostatic and liver and kidney. 9. 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 study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment.
- Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment .
Exclusion Criteria:
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Pregnant or lactating women.
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Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
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Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled.
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Subjects with any uncontrolled active infection (Except for prophylactic treatment).
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Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
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Subjects who have received autologous BCMA CAR-T therapy
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Subjects who have received allogeneic stem cell transplantation for MM.
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Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF.
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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.
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Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids.
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Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion.
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Subjects have severe allergy history.
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Subjects who have any uncontrolled disease conditions within 6 months prior to the screening.
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LVEF < 50%
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Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation.
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Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy.
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Subjects with malignant tumors that have not been cured in the past 5 years or at the same time, except for very low malignant tumors.
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Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement.
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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.
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Subjects who have received major surgery 2 weeks prior to the screening or plan to receive major surgery within 4 weeks after study treatment (excluding cataract and other local anesthesia).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital, Soochow University | Suzhou | Jiangsu | China | 215000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- CARsgen Therapeutics Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT0594CP-CG6021