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Trial Title:
Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
NCT ID:
NCT05893693
Condition:
Relapsed and/or Refractory Multiple Myeloma
Plasma Cell Leukemia in Relapse
Conditions: Official terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Biological
Description:
CT0594CP
Arm group label:
CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ]
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
Detailed description:
This is an open-label, single arm, dose-escalation clinical 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
Criteria for eligibility:
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, with MM or Plasma Cell Leukemia, who have received regimens and have
medical records in the past.
4. According to the IMWG consensus for relapsed and/or refractory multiple myeloma or
Plasma Cell Leukemia, the disease is in a progressive state
5. Subjects should have measurable disease.
5.1 Serum M protein ≥ 5 g / L;
5.2 24-hour urinary M-protein ≥ 200 mg;
5.3 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.
5.4 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.
10. 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:
1. Pregnant or lactating women.
2. Subjects positive for any following tests: human immunodeficiency virus (HIV)
antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
3. 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.
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) ≤ 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 received allogeneic stem cell transplantation for MM.
8. Subjects who have received autologous stem cell transplantation less than 12 weeks
before ICF.
9. 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.
10. Subjects who have received systemic glucocorticoids within 7 days before infusion,
except inhaled steroids.
11. Subjects who have been received live attenuated vaccine within 8 weeks or
inactivated vaccine within 4 weeks before lymphodepletion.
12. Subjects have severe allergy history.
13. Subjects who have any uncontrolled disease conditions within 6 months prior to the
screening.
14. LVEF < 50%
15. Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation.
16. Subjects known to have active autoimmune diseases including but not limited to
psoriasis, rheumatoid arthritis and other conditions that require long-term
immunosuppressive therapy.
17. 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.
18. Subjects who have central nervous system (CNS) metastases or symptomatic CNS
involvement.
19. 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.
20. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Tongji Hospital
Address:
City:
Shanghai
Zip:
200333
Country:
China
Status:
Recruiting
Contact:
Last name:
Aibin Liang
Phone:
+8618601670600
Email:
lab7182@tongji.edu.cn
Start date:
April 12, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Aibin Liang，MD，Ph.D.
Agency class:
Other
Collaborator:
Agency:
CARsgen Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Shanghai Tongji Hospital, Tongji University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05893693
