This is a single center, open-label, dose-escalation/expansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma，B-cell lymphoma and other hematologic malignancies.
White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);
Platelet count ≥ 50 × 10e9/L (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;
Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.
Having received CAR-T therapy targeting the same molecule;
Having received other immunotargeted therapy targeting the same molecules;
Pregnant or lactating women;
Having received curative therapy, and no known active disease in the ≥ 3 years prior to the enrollment;
Single group
CAR-T
Biological/VaccineCAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting human B cell maturation antigen (BCMA) ,CD19 or CD-7 etc. target molecules of other hematologic malignancies.
Number of patients with dose-limiting toxicity (DLT)
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03).
Maximum Tolerated Dose (MTD)
At least 6 subjects in the MTD dose group must complete the DLT assessment.
Adverse Event
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during medical tests (e.g. laboratory tests, electrocardiogram, imaging examinations or physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MeDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
Recommended Phase 2 Dose (RP2D)
To determine after all subjects in the Phase 1 dose-escalation study completed DLT observation
Stringent complete response rate (sCRR)
The definition of sCRR is the proportion of subjects achieving sCR confirmed by efficacy re-assessment after a minimum interval of three months. Efficacy assessment for multiple myeloma only.
Progression-free Survival (PFS)
The time interval from the first administration of the investigational drug to the first observation of disease progression is calculated, considering the date of entry for patients who died for reasons other than disease progression before progression occurred.
Overall Survival (OS)
OS is the time from the start of cell infusion to the death of the subject.
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