Overview

A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)

Status:
Not yet recruiting
Trial end date:
2039-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nanjing IASO Biotherapeutics Co.,Ltd
Criteria
Inclusion Criteria:

1. 18 to 70 years old, male or female;

2. Newly diagnosed as high-risk multiple myeloma:

- Revised Multiple Myeloma International Staging System (R-ISS) stage 3;

- Double-hit or triple-hit according to FISH test.

3. Presence of measurable lesions during screening according to any of the following
criteria:

- The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow
cytology, bone marrow biopsy histology or flow cytometry;

- Serum monoclonal protein (M-protein) level: M protein ≥10 g/L for IgG type, M
protein ≥5g/L for IgA, IgD, IgM, and IgE type;

- Urine M protein level ≥200 mg/24 hours;

- Light chain multiple myeloma without measurable lesions in serum or urine: the
affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light
chain ratio;

4. ECOG score of 0 or 1;

5. Expected survival time ≥ 12 weeks;

6. Subjects must have appropriate organ functions and meet all the following laboratory
test requirements before enrollment:

- Hematology: Absolute neutrophil count (ANC) ≥ 1×10^9/L (prior growth factor
support is allowed, but supportive treatment within 7 days before laboratory test
is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10^9/L;
platelets≥75×10^9/L (blood transfusion support within 7 days before laboratory
test is not allowed); hemoglobin ≥60 g/L (without red blood cell [RBC]
transfusion within 7 days before laboratory test; recombinant human
erythropoietin is allowed);

- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase
(AST)≤2.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;

- Renal function: creatinine clearance calculated according to Cockcroft-Gault
formula≥ 40 ml/min.

- Coagulation function: fibrinogen ≥1.0 g/L; activated partial thromboplastin
time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;

- Blood oxygen saturation>91%;

- Left ventricular ejection fraction (LVEF) ≥50%;

7. Subjects and their spouses agree to take effective tools or contraceptive measures
(safe period contraception is not included) from the time the subject signs the
informed consent form until one year after the CAR-T cell infusion.

Exclusion Criteria:

1. Patient who needs chronic use of immunosuppressive agents;

2. Patient with hypertension that cannot be controlled by medication;

3. Severe heart disease: including but not limited to unstable angina, myocardial
infarction (within 6 months before screening), congestive heart failure (New York
Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;

4. Unstable systemic diseases judged by the investigator: including but not limited to
severe liver, kidney or metabolic diseases that require drug treatment;

5. Patients with malignant tumors other than multiple myeloma within 5 years before
screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous
cell skin cancer, local prostate cancer after radical resection, and those after
radical resection Ductal carcinoma in situ of breast;

6. Patient with a history of solid organ transplantation;

7. Patient who is suspected with or with symptoms of central nervous system invasion by
plasma cell tumors;

8. Multiple myeloma patients with plasma cell leukemia;

9. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and
detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV)
antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human
immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test
positive; syphilis test positive;

10. Women who are pregnant or breastfeeding;

11. Patient with mental illness or disturbance of consciousness or central nervous system
disease;

12. Major surgery history within 2 weeks before entering the study, or scheduled surgery
during the study period or within 2 weeks after the study treatment;

13. Other situations considered unsuitable by the investigator.