Actively Recruiting
A Study to Evaluate the Efficacy and Safety of CD7 CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases
Led by Zhejiang University · Updated on 2025-08-13
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a treatment involving CD7 CAR-T cells followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) for patients with CD7-positive relapsed or refractory malignant hematologic diseases. This single-arm, open-label, phase I/II study aims to assess safety outcomes and is sponsored by Zhejiang University. The trial focuses on patients with specific types of acute leukemia that are resistant to or have relapsed after standard treatments. Participants will receive an infusion of CD7 CAR-T cells designed to target cancer cells expressing CD7. This treatment is followed by allo-HSCT as a bridging therapy to further support recovery. The study includes monitoring of the CAR-T cell expression, cytokine levels related to CAR-T therapy, and various survival and remission outcomes over time, with evaluations scheduled from weeks to months after treatment. During the study, participants will undergo assessments including adverse event monitoring up to 28 days after CAR-T infusion, laboratory tests, and evaluations of remission and survival status up to two years post-treatment. Researchers will also monitor bone marrow transplantation success and minimal residual disease over extended follow-up periods. The total participation time and detailed evaluation schedules are designed to thoroughly understand the safety and effects of this combined treatment approach.
CONDITIONS
Brief Title
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Male or female, 18 years of age or older
- Anticipated survival time more than 12 weeks
- ECOG performance status of 2 or less
- Diagnosis of CD7 positive acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) according to NCCN guidelines
- Refractory or relapsed CD7 positive acute leukemia meeting one of the following: no complete remission after standard chemotherapy, first remission lasting 12 months or less, no response to one or more salvage therapies, or multiple relapses
- Philadelphia chromosome negative or unable to tolerate tyrosine kinase inhibitors, or Philadelphia chromosome positive not responding to TKI treatments
- Normal lung function with oxygen saturation above 92% without oxygen support
- Blood tests within specified limits: AST and ALT ≤ 2.5 times upper normal limit, total bilirubin ≤ 1.5 times upper normal limit, creatinine clearance ≥ 30 mL/min, lipase and amylase ≤ 2 times upper normal limit
- Fertile men and women of childbearing potential must agree to use effective contraception from consent signing until 2 years after study drug use
- Negative pregnancy test for women of reproductive age at screening
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Pregnant or breastfeeding women
- Active infections without cure
- Prolonged QT interval or severe heart disease
- Known hypersensitivity or intolerance to drugs used in the study
- Recent anticancer chemotherapy or drug treatment within 2 weeks before screening
- Previous cancers requiring treatment or with recurrence evidence within 5 years before screening
- Significant central nervous system lesions or involvement
- Terminal organ damage from autoimmune diseases requiring systemic immunosuppressive therapy within past 2 years
- Severe active infections or bleeding/coagulation disorders
- Autologous hematopoietic stem cell transplantation within 8 weeks before screening or planned during study
- Participation in other drug clinical trials within 4 weeks or 5 half-lives before screening
- Any condition increasing patient risk or interfering with study results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive CD7 CAR-T cell infusion followed by allogeneic hematopoietic stem cell transplantation as a bridge therapy to treat refractory or relapsed CD7 positive malignant hematologic diseases.
Multiple visits for CAR-T infusion and transplantation procedures
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and long-term outcomes including survival and disease status after treatment.
Regular visits for assessments at multiple timepoints up to 2 years
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
Y
Yongxian HU, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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