Actively Recruiting
Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase I/II Clinical Trial
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
80
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
T
The General Hospital of Western Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD7 CAR T-cell therapy for patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL). This multi-center, open-label, non-randomized phase I/II trial includes patients who have limited treatment options after standard therapies and aims to understand how well these therapies work and their side effects. Participants will receive one of three types of CD7 CAR T-cell treatments depending on their history: autologous cells from their own blood, donor cells from a previous hematopoietic stem cell transplant (HSCT), or donor cells from a new donor. The trial involves infusion of these specially prepared cells and follows patients closely to observe their response and any toxicities. During the study, patients will be monitored for dose-limiting toxicities within 21 days after infusion in phase I and overall response at about 3 months in phase II. Additional follow-up will track safety, survival, remission duration, and immune cell levels for up to two years after treatment. The trial enrolls patients aged 1 to 70 years and involves regular assessments including laboratory tests and clinical evaluations over this period.
CONDITIONS
Brief Title
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CD7-positive refractory or relapsed T-cell malignancies after standard treatments have failed
- Tumor cells positive for CD7 antigen by flow cytometry or immunohistochemistry with specified expression levels
- Male or female aged between 1 and 70 years
- No severe allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Life expectancy of at least 60 days as determined by the investigator
- Signed informed consent form appropriate to age and comprehension
You will not qualify if you...
- Presence of intracranial hypertension or unconsciousness
- Acute heart failure or severe arrhythmia
- Acute respiratory failure
- Other malignant tumors besides the target disease
- Diffuse intravascular coagulation
- Elevated serum creatinine or blood urea nitrogen exceeding 1.5 times normal
- Sepsis or uncontrolled infection
- Uncontrolled diabetes mellitus
- Severe psychological disorder
- Obvious cranial lesions detected by MRI
- Allergic constitution
- Organ transplant recipients
- Pregnant or breastfeeding individuals
- Active, uncontrolled infections including hepatitis B, hepatitis C, HIV, or syphilis
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 - Not specified
Peripheral blood mononuclear cells are collected from participants or donors for the production of CD7 CAR T cells.
1 visit (in-person)
Duration - 21 days post infusion for dose-limiting toxicity assessment
Participants receive autologous or donor-derived CD7 CAR T-cell therapy for refractory or relapsed T-cell malignancies.
Initial infusion visit and subsequent visits during first 3 weeks
Duration - Up to 2 years post infusion
Participants are monitored for overall response, safety, progression-free survival, duration of remission, overall survival, and immune cell levels.
Regular follow-up visits for up to 2 years
Trial Site Locations
Total: 4 locations
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
2
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China, 200435
Actively Recruiting
3
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China, 201418
Actively Recruiting
4
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China, 610083
Not Yet Recruiting
Research Team
Z
zhuojun ling
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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