CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
NCT ID: NCT05827835
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2023-04-30
2027-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
R/R CD7+Malignant Hematologic Diseases
CD7 CAR-T cells injection
CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Allogeneic hematopoietic stem cell transplantation
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
Interventions
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CD7 CAR-T cells injection
CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Allogeneic hematopoietic stem cell transplantation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Principal Investigators
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He Huang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TXB2022023
Identifier Type: -
Identifier Source: org_study_id
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