Muedzo wekiriniki paCAR-T Cell kurapwa kune varwere vane BCMA/TACI-positive vakadzoka zvakare uye/kana refractory multiple myeloma.

Pfupiso Pfupi:

Chidzidzo chaApril CAR-T masero kurapa kune varwere vane BCMA / TACI yakanaka yakadzoka zvakare uye / kana refractory multiple myeloma

Ruzivo Ruzere:

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

Zvikonzero

Inosanganisira Maitiro:

1. Histologically confirmed diagnosis of BCMA/TACI+ akawanda myeloma (MM)：
   1. Varwere vane MM vakadzoka zvakare mushure mekurapa kweBCMA CAR-T; Kana MM ine yakanaka BCMA/TACI kutaura;
   2. Kudzoka zvakare mushure mekuita hematopoietic stem cell transplantation;
   3. Mhosva dzine zvinodzokororwa zvakanaka zvishoma zvakasara chirwere;
   4. Extramedullary lesion, iyo yakaoma kubvisa nechemotherapy kana radiotherapy.
2. Murume kana mukadzi ane makore 18–75;
3. Zvose bilirubin ≤ 51 umol / L, ALT uye AST ≤ 3 nguva dzepamusoro dzepamusoro, creatinine ≤ 176.8 umol / L;
4. Echocardiogram inoratidza kuruboshwe ventricular ejection fraction (LVEF) ≥50%;
5. Hapana hutachiona hunoshanda mumapapu, ropa reoxygen saturation mumhepo yemukati ndeye ≥ 92%;
6. Inofungidzirwa nguva yekupona ≥ 3 mwedzi;
7. ECOG maitiro ekuita 0 kusvika ku2;
8. Varwere kana vachengeti vavo vepamutemo vanozvipira kutora chikamu muchidzidzo uye kusaina chibvumirano chavanoziva.

Kuregererwa Criteria:

Zvidzidzo zvine chero yeiyi inotevera nzira yekusabatanidzwa vanga vasina kukodzera muyedzo uyu:

1. Nhoroondo ye craniocerebral trauma, conscious disorder, pfari, cerebrovascular ischemia, uye cerebrovascular, hemorrhagic zvirwere;
2. Electrocardiogram inoratidza nguva yakareba yeQT, zvirwere zvemwoyo zvakakomba zvakadai seyakanyanya arrhythmia munguva yakapfuura;
3. Vakadzi vane pamuviri (kana vanoyamwisa);
4. Varwere vane hutachiona hwakanyanya hunoshanda (kunze kwehutachiona hwehutachiwana huri nyore uye bhakitiriya pharyngitis);
5. Kushanda kwehutachiona hwehutachiona hweH hepatitis B kana hutachiona hweH hepatitis C;
6. Concurrent therapy ne systemic steroids mukati memavhiki e2 vasati vaongororwa, kunze kwevarwere munguva pfupi yapfuura kana iye zvino vari kugamuchira mune haled steroids;
7. Yakamborapwa nechero CAR-T sero chigadzirwa kana imwe genetically modified T cell therapies;
8. Creatinine> 2.5 mg/dl, kana ALT/AST> 3 nguva dzenguva dzose, kana bilirubin> 2.0 mg/dl;
9. Zvimwe zvirwere zvisingadzoreki zvakanga zvisina kukodzera kuedzwa uku;
10. Varwere vane hutachiwana hweHIV;
11. Chero mamiriro ezvinhu anotendwa nemuongorori anogona kuwedzera njodzi yevarwere kana kukanganisa mhedzisiro yekudzidza