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Ukuhlolwa komtholampilo ekwelapheni kwamaseli e-CAR-T ezigulini ezine-BCMA/TACI-positive ezibuyelwe kabusha kanye/noma i-myeloma eminingi ephikisayo

Ukuhlolwa komtholampilo kumdlavuza
Lena ingalo eyodwa, ilebula evulekile, ucwaningo lwesikhungo esisodwa. Lolu cwaningo lukhonjiswe ukuphinda kubuyele emuva noma okuphikisayo i-BCMA/TACI positive relapsed kanye/noma i-refractory multiple myeloma. Ukukhethwa kwamazinga omthamo kanye nenani lezifundo kusekelwe ekuhlolweni komtholampilo kwemikhiqizo efanayo yangaphandle. Kuzobhaliswa iziguli ezingama-36. Inhloso eyinhloko ukuhlola ukuphepha, okucatshangelwa kakhulu ukuphepha okuhlobene nomthamo.

Yabelana ngalokhu okuthunyelwe

Isifinyezo esifushane:

Ucwaningo luka-APRIL Ukwelashwa kwamaseli e-CAR-T ezigulini ezine-BCMA/TACI positive ezibuyelwe kabusha kanye/noma i-myeloma eminingi ephikisayo

Imininingwane eningiliziwe:

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 izivivinyo zokwelashwa of similar foreign products. 36 patients will be enrolled. The primary objective is to explore safety; the main consideration is dose-related safety.

Imigomo

Imigomo Yokufaka:

  1. Histologically confirmed diagnosis of BCMA/TACI+ i-myeloma eminingi (MM)：
    1. Iziguli ezine-MM ezibuyele emuva ngemva kokwelashwa kwe-BCMA CAR-T; Noma i-MM enezisho ezinhle ze-BCMA/TACI;
    2. Ukubuyela emuva ngemva kokufakelwa kwe-hematopoietic stem cell;
    3. Amacala anesifo esincane esihlala sikhona;
    4. I-Extramedullary lesion, okunzima ukuyiqeda nge-chemotherapy noma nge-radiotherapy.
  2. Owesilisa noma owesifazane oneminyaka engu-18-75;
  3. Isamba se-bilirubin ≤ 51 umol / L, ALT kanye ne-AST ≤ izikhathi ezingu-3 zomkhawulo ophezulu wejwayelekile, i-creatinine ≤ 176.8 umol / L;
  4. I-Echocardiogram ibonisa ingxenyenamba ye-ventricular ejection (LVEF) ≥50%;
  5. Akukho ukutheleleka okusebenzayo emaphashini, ukugcwala komoyampilo wegazi endlini yasendlini ≥ 92%;
  6. Isikhathi sokusinda esilinganiselwe ≥ izinyanga ezi-3;
  7. Isimo sokusebenza kwe-ECOG 0 kuya ku-2;
  8. Iziguli noma abanakekeli bazo abasemthethweni bayavolontiya ukubamba iqhaza ocwaningweni futhi basayine imvume enolwazi.

Imigomo Yokukhishwa:

Izihloko ezinanoma iyiphi imibandela elandelayo yokukhishwa bezingafaneleki kulolu cwaningo:

  1. Umlando wokuhlukumezeka kwe-craniocerebral, ukuphazamiseka kwengqondo, isithuthwane, i-cerebrovascular ischemia, kanye nezifo ze-cerebrovascular, hemorrhagic;
  2. I-Electrocardiogram ibonisa isikhawu se-QT eside, izifo zenhliziyo ezinzima njenge-arrhythmia enzima esikhathini esidlule;
  3. abesifazane abakhulelwe (noma abancancisayo);
  4. Iziguli ezinezifo ezinzima ezisebenzayo (ngaphandle kokutheleleka kwe-urinary tract kanye ne-bacterial pharyngitis);
  5. Ukutheleleka okusebenzayo kwegciwane le-hepatitis B noma igciwane le-hepatitis C;
  6. Ukwelashwa okuhambisanayo ne-systemic steroids emasontweni ama-2 ngaphambi kokuhlolwa, ngaphandle kweziguli ezisanda kuthola noma okwamanje ezithola i-haled steroids;
  7. Ngaphambilini yokwelashwa nganoma imuphi umkhiqizo weseli ye-CAR-T noma ezinye izindlela zokwelapha zamaseli e-T ashintshwe ngofuzo;
  8. I-Creatinine> 2.5 mg/dl, noma i-ALT/AST> izikhathi ezi-3 zamanani ajwayelekile, noma i-bilirubin> 2.0 mg/dl;
  9. Ezinye izifo ezingalawuleki ebezingafanele lolu cwaningo;
  10. Iziguli ezine-HIV;
  11. Noma yiziphi izimo umphenyi akholelwa ukuthi zingandisa ingozi yeziguli noma ziphazamise imiphumela yocwaningo

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