Actively Recruiting
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
Led by The General Hospital of Western Theater Command · Updated on 2024-09-05
200
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
Sponsors
T
The General Hospital of Western Theater Command
Lead Sponsor
Y
YakeBiotech Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute leukemia
- Acute leukemia that is refractory or relapsed with poor response to standard chemotherapy
- At least 2 weeks or 5 half-lives since prior chemotherapy (except immune checkpoint inhibitors, which require 3 half-lives)
- Previous treatment-related toxicities stabilized to grade 1 or less (except minor issues like hair loss)
- Age between 14 and 65 years
- Physical condition score (ECOG) between 0 and 3
- No active infection or graft-versus-host disease
- Expected survival of at least 3 months
- Adequate kidney, liver, lung, and heart function as defined by specific lab and clinical measures
- Negative pregnancy test for women who can become pregnant (infertile women excluded)
You will not qualify if you...
- History of other cancers or carcinoma in situ unless disease-free for at least 3 years
- Uncontrolled or suspected fungal, bacterial, viral, or other infections
- Known HIV infection
- Positive for hepatitis B or C unless viral DNA/RNA tests are negative and monitored monthly
- Past or current central nervous system diseases such as seizures or dementia
- Severe heart conditions including recent myocardial infarction or heart failure
- Expected need for emergency treatment due to rapid tumor growth within 6 weeks
- Primary immune deficiency
- Recent history of deep vein thrombosis or pulmonary embolism
- Medical conditions interfering with safety or study evaluation
- Severe allergic reactions to study drugs
- Live vaccine within 6 weeks before pre-treatment
- Pregnant or breastfeeding women
- Not agreeing to use effective contraception during and 6 months after treatment
- Difficulty complying with study procedures or follow-up
- Recent autoimmune disease damage or immunosuppressive treatments unless disease-free for 3 years
- Participation in other clinical trials during the same period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Actively Recruiting
Research Team
H
Hai Yi, Ph.D
CONTACT
S
Sihan Lai
CONTACT
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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