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

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

NCT ID: NCT05827835

Condition: Hematologic Diseases
Neoplasms

Conditions: Official terms:
Hematologic Diseases

Conditions: Keywords:
allo-HSCT
CD7 CAR-T

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CD7 CAR-T cells injection
Description: CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Arm group label: Treatment Group

Intervention type: Other
Intervention name: Allogeneic hematopoietic stem cell transplantation
Description: In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Arm group label: Treatment Group

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The first affiliated hospital of medical college of zhejiang university

Address:
City: Hangzhou
Zip: 310003
Country: China

Status: Recruiting

Contact:
Last name: He Huang, MD

Phone: 86-13605714822
Email: hehuangyu@126.com

Contact backup:
Last name: Yongxian Hu, MD

Phone: +8615957162012
Email: huyongxian2000@aliyun.com

Start date: April 30, 2023

Completion date: April 25, 2025

Lead sponsor:
Agency: Zhejiang University
Agency class: Other

Collaborator:
Agency: Yake Biotechnology Ltd.
Agency class: Industry

Source: Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05827835