Orci iudicium de CAR-T Cell Lorem aegrotis cum BCMA/TACI-positivis relapsis et/vel refractariis myeloma multiplex

Breviter:

A studio APRILIS CAR-T cellulae Lorem pro aegris cum BCMA/TACI positivum relapsus et/vel refractarium multa myeloma

Enarratio:

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selection of dose levels and the number of subjects are based on orci iudiciis of similar foreign products. 36 patients will be enrolled. The primary objective is to explore safety; the main consideration is dose-related safety.

criteria

Criteria inclusion:

1. Histologically confirmed diagnosis of BCMA/TACI+ multa myeloma (MM)：
   1. Aegris cum MM qui relapsus est post BCMA CAR-T justo; Vel MM cum expressione positivo BCMA/TACI;
   2. Relapsus post cellulam transplantationem hematopoieticam caulis;
   3. Causae cum recurrente morbo positivo minimo residuo;
   4. Laesio extramedullaria, quae difficile est per chemotherapyam vel radiotherapiam eradicare.
2. Masculus an femina senex 18-75 annis;
3. Totalis bilirubin ≤ 51 umol/L, ALT et AST ≤ 3 ter- rarum superiorum normalium, creatinine ≤ 176.8 umol/L;
4. Echocardiogrammus ostendit ≥50% ≥XNUMX% eiectio ventricularis sinistri (LVEF);
5. Nulla infectio activa in pulmone, satietatem sanguinis oxygeni in indoorairis ≥ 92% est;
6. Aestimatur tempus superstes ≥ 3 mensium;
7. ECOG status perficientur 0 ad 2;
8. Aegroti vel custodes legales eorum voluntarii ad participandum in tablino subsignando consensum certiorem faciunt.

Criteria exclusio:

Subiectis cum quibusvis exclusio sequentium indiciis ad hoc iudicium non eligibile;

1. Historia trauma craniocerebralis, commotio conscia, epilepsia, ischemia cerebrovascular, et morbi cerebrovasculares, hemorrhagic;
2. Electrocardiogram ostendit longum QT intervallum, graves cordis morbos sicut arrhythmia in praeteritum graves;
3. Gravida (or lactating) feminae;
4. Aegris cum gravibus infectionibus activis (exclusis infectio simplicis tractus urinarii et pharyngitis bacterial);
5. Infectio activa viri hepatitis B virus vel hepatitis C virus;
6. Lorem concurrentibus cum steroidibus systemicis intra 2 septimanas ante protegendo, praeter aegros recenter vel currently in steroidibus capiendis accipiendis;
7. Antea tractatur de quolibet productum CAR-T cellae vel T cellae therapiae genealiter mutatae;
8. Creatinum > 2.5 mg/dl, vel ALT / AST > 3 tempora summarum normalium, vel bilirubinum > 2.0 mg/dl;
9. Alii morbi impotentes ad hoc iudicium idonei non erant;
10. Aegris VIH contagio;
11. Quaevis condiciones quas inquisitor credit periculum aegrorum augere vel impedire cum eventibus studii potest