CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

Launched by ZHEJIANG UNIVERSITY · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain blood cancers that are difficult to treat, specifically those that test positive for a marker called CD7. The treatment involves using a special type of therapy called CD7 CAR-T, followed by a procedure known as allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main goal of the study is to see if this new treatment is safe for patients who have already tried other therapies without success.

To be eligible for the trial, participants should be between 18 and 75 years old and have a specific type of leukemia that has either come back after treatment or hasn't responded to previous therapies. They should also have a good chance of survival for more than 12 weeks and meet certain health criteria. Participants will receive the CAR-T therapy and will be closely monitored for any side effects or reactions. It's important to note that this study is currently recruiting, and patients who are interested should discuss it with their healthcare team to see if they qualify.

Gender

ALL

Eligibility criteria

• 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 ≤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.