anti-cd7 u-car-t cell therapy for t/nk cell hematologic malignancies

Conditions: T-cell Leukemia; T-cell Lymphoma

Summary: the prognosis of patients with relapsed and/or refractory t-cell hematologic malignancies is poor due to lacking sufficient treatment.anti-cd(cluster of differentiation antigen)19 car(chimeric antigen receptor)-t cell therapies are efficient for patients with b-cell hematologic malignancies. as for t-cell hematologic malignancies, cd7 is a promising target expressed on most malignant t cells. the outcome of cd-7 car-t cell therapy pre-clinical experiments is cheerful.however, how to select the functional t cells from the malignant t cells is a challenge. in addition to this, auto-car-t cell therapy is not affordable for the majority of patients. using t cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-cd7 universal car-t cells could be accessible and affordable, which is adapted for patients with cd7+ relapsed and/or refractory t/nk-cell hematologic malignancies.


Eligibility criteria:
inclusion criteria: * 1. diagnosis of recurrent t-cell acute lymphoblastic leukemia (t-all), t-cell acute lymphoblastic lymphoma (t-lly), or t-non-hodgkin lymphoma (t-nhl, including angioimmunoblastic t-cell lymphoma (aitl), enteropathy-associated t-cell lymphoma (eatl), monomorphic epitheliotropic intestinal t-cell lymphoma (meitl), peripheral t-cell lymphoma (ptcl) nos, anaplastic large cell lymphoma (alcl), adult t-cell leukemia/lymphoma, t cell prolymphocytic leukemia with symptomatic disease, extranodal nk/t cell lymphoma, mycosis fungoides/ sezary syndrome stage iib or higher)) 2. cd7-positive tumor (≥20% cd7 positive blasts by flow cytometry or immunohistochemistry (tissue)） 3. hgb ≥ 7.0 (can be transfused) 4. life expectancy greater than 12 weeks 5. informed consent explained to, understood by and signed by the patient/guardian. patient/guardian is given a copy of informed consent. exclusion criteria: 1. pregnant or lactating. 2. tumor in a location where enlargement could cause airway obstruction (per investigator discretion). 3. active infection with hiv or htlv. 4. clinically significant viral infection or uncontrolled viral reactivation of ebv(epstein-barr virus), cmv(cytomegalovirus), adv(adenovirus), bk-virus, or hhv(human herpesvirus)-6. 5. any of the following cardiac criteria: atrial fibrillation/flutter; myocardial infarction within the last 12 months; prolonged qt syndrome or secondary prolonged qt, per investigator discretion. cardiac echocardiography with lvsf (left ventricular shortening fraction)\<30% or lvef(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. cardiac dysfunction nyha(new york heart association) iii or iv (confirmation of absence of these conditions on echocardiogram within 12 months of treatment). 6. cns abnormalities: presence of cns(central nervous system)-3 disease defined as detectable cerebrospinal blast cells in a sample of csf(cerebrospinal fluid) with ≥ 5 wbc( white blood cell)s per mm3 (unless negative by the steinherz/bleyer algorithm); presence of any cns disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement.