| Eligibility |
Inclusion Criteria:
- The subject must meet all of the following criteria:
1. 18-65 years old;
2. Relapsed or refractory T-NHLs, including peripheral T-cell lymphoma, not
otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL),
ALK-positive ALCL, ALK-negative Image result for anaplastic large cell lymphoma
(ALCL), enteropathy-related T-cell lymphoma, hepatosplenic T-cell lymphoma, etc.;
3. Previously received =2 lines of treatment without a complete response;
4. Immunohistochemical detection of tumor cells CD147 positive;
5. ECOG score 0-2;
6. The collection of mononuclear cells can be performed upon the judgment of the
researcher;
7. No contraindications for allogeneic hematopoietic stem cell transplantation
(AlloHCT);
8. Have donors for AlloHCT;
9. Agree for sequential treatment of AlloHCT;
10. Without serious organ dysfunction in 2 weeks before CAR-T infusion:
1. Heart: without arrhythmia, LVEF=50%, and without pericardial effusion;
without heart failure (NYHA class III or IV) within12 months before CAR-T
infusion; without myocardial infarction within 12 months before CAR-T
infusion; without long-QT syndrome or secondary QT interval prolongation;
2. Liver: ALT<2 times the upper limit of normal (ULN) and TBIL<1.5 times ULN,
without active hepatitis;
3. APTT and PT<1.5 times ULN;
4. Kidney: Serum creatinine <1.5 mg/dl; or if the serum creatinine exceeds the
upper limit, eGFR (CKD-EPI formula) needs to be > 50 ml/min;
5. Fingertip blood oxygen saturation = 92%.
11. Estimated survival = 3 months;
12. Sexually active patients must be willing to use an effective method of birth
control during the study period and within 6 months after the study ending, and
male partners should use condoms;
13. The patient is willing to join this clinical trial and sign an informed consent.
Exclusion Criteria:
- Anyone who has one or more of the following:
1. A history of other malignancies with a disease-free period < 5 years (except for
cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and
gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
2. Those who have received allogeneic hematopoietic stem cell transplantation or
organ transplantation;
3. Patients with bone marrow involvement;
4. Those who are allergic to the biological agents in CAR-T cell product ;
5. Pregnant or breastfeeding;
6. Active bacterial, fungal or viral infection;
7. Receiving systemic hormone therapy 1 week before participating in the clinical
trial;
8. Have received other gene therapy before;
9. HBV or HCV infection or carrier is defined as: HBsAg positive or HBV-DNA
positive; anti-HCV positive and HCV-RNA positive;
10. Active HIV infection;
11. Clinical diagnosis of virus infection or uncontrolled virus activation, including
cytomegalovirus (CMV), adenovirus (ADV), BK virus or human herpesvirus 6 (HHV-6),
etc.;
12. Central nervous system lymphoma (CNSL) is defined as the presence of =5 tumor
cells/ ul in cerebrospinal fluid (CSF) or MRI suggested CNSL; any other CNS
diseases, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia,
cerebellar disease or any autoimmune disease involving the central nervous
system, or received treatment for central nervous system or brain metastasis
(radiotherapy, surgery or other treatments);
13. Imaging determined lung infection;
14. Inappropriate to participate in the trial with investigators' decision.
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