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โ† Trials
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CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

This is a single-arm, open-label, single-center, phase I/II 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * Male or female, older than 18 years (including 18 years) * Anticipated survival time more than 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status โ‰ค2 * 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 โ‰ค 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) โ‰ค 2.5 ร— (ULN) * b. Total bilirubin โ‰ค 1.5 ร— ULN * c. 24-hour serum creatinine clearance โ‰ฅ 30 mL/min * d. Lipase and amylase โ‰ค 2 ร— 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.
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What it tests

  • CD7 CAR-T cells injection
  • Allogeneic hematopoietic stem cell transplantation
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Where

1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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