cd7 car-t bridging to allohsct for r/r cd7+malignant hematologic diseases

Conditions: Hematologic Diseases; Neoplasms

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 car-t bridging to allo-hsct therapy for patients with cd7-positive relapsed or refractory malignant hematologic diseases


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form (icf) * male or female, 18-75 years old * anticipated survival time more than 12 weeks * eastern cooperative oncology group (ecog) performance status ≤2 * according to the national comprehensive cancer network (nccn) clinical practice guidelines for acute lymphocytic leukemia and acute myeloid leukemia (2016. v1), patients diagnosed as cd7+all and aml * consistent with r/r cd7+acute leukemia diagnosis, including any of the following conditions * a. no cr after standard chemotherapy * b. the first induction reaches cr, but cr ≤ 12 months * c. patients with r/r cd7+acute leukemia have not responded to the first or multiple remedial treatments * d. multiple recurrences * philadelphia chromosome negative (ph -) subjects; or cannot tolerate tyrosine kinase inhibitor (tki) treatment; or philadelphia chromosome positive (ph+) subjects who did not respond to both tki treatments * normal lung function, oxygen saturation greater than 92% without oxygen inhalation * the blood biochemical test results are consistent with the following results * a. (ast) and (alt) ≤ 2.5 × (uln) * b. total bilirubin ≤ 1.5 × uln * c. 24-hour serum creatinine clearance ≥ 30 ml/min * d. lipase and amylase ≤ 2 × uln * fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. women of reproductive age include pre menopausal women and women within 2 years after menopause. the blood pregnancy test for women of reproductive age must be negative at screening exclusion criteria: * patients with the history of epilepsy or other cns disease * pregnant or breastfeeding * active infection with no cure * patients with prolonged qt interval time or severe heart disease * have experienced hypersensitivity or intolerance to any drug used in this study * patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening * previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening * clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis * in the past 2 years, terminal organ damage caused by autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs * severe active viral, bacterial, or uncontrolled systemic fungal infections; genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding * patients who received autologous hematopoietic stem cell transplantation (asct) within 8 weeks before screening, or who plan to undergo asct during this study * participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (t1/2) before screening * any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Keywords: allo-hsct cd7 car-t