Actively Recruiting
U69-CART-Cells For R/R T-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-19
12
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.
CONDITIONS
Official Title
U69-CART-Cells For R/R T-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent and ability to complete study procedures and follow-up
- Age between 15 and 75 years at consent; minors must have guardian consent
- Confirmed diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma per 2022 WHO classification
- For T-ALL: at least 5% blasts in bone marrow or blood with relapse or refractory disease
- For T-LBL: at least one measurable lesion as defined by imaging and relapsed/refractory disease
- Confirmed CCR9 positivity on tumor cells by flow cytometry or immunohistochemistry
- ECOG performance status between 0 and 2
- Estimated life expectancy greater than 3 months
- Adequate bone marrow reserve with specified blood counts
- Adequate liver, kidney, heart, and lung function within defined limits
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Adequate venous access for leukapheresis or blood draw
You will not qualify if you...
- Diagnosis of other malignancies within 3 years unless disease-free for over 3 years with low recurrence risk
- History or presence of central nervous system disorders unrelated to the disease
- Previous cell therapies targeting CCR9, including CAR-T or CAR-gamma-delta T cells
- Significant active central nervous system or cranial nerve lesions deemed risky
- Recent systemic corticosteroid use except low-dose replacement
- Donor lymphocyte infusion within 6 weeks before leukapheresis
- Anti-T-cell antibody therapy within 4 weeks before leukapheresis
- Positive viral markers with active infection or high viral load
- Active or uncontrolled infections needing systemic treatment
- Recent serious cardiac events or uncontrolled heart or lung conditions
- Unstable severe systemic diseases
- Active autoimmune disease or immunodeficiency
- History of severe drug allergies related to study drugs
- Live vaccine within 6 weeks before screening
- Pregnancy or breastfeeding
- Autoimmune disease requiring systemic immunosuppressive treatment in past 2 years
- Recent allogeneic stem cell transplant or graft-versus-host disease treatment
- Participation in another interventional clinical trial within 4 weeks
- Inability to comply with study procedures or considered unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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