Actively Recruiting
CD5 Chimeric Antigen Receptors (CAR) T Cells for Relapsed or Refractory T-Cell Malignancies Multi-center Open-label Phase 1/2 Clinical Trial
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
54
Participants Needed
4
Research Sites
26 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 anti-CD5 CAR-T cell therapy in patients with CD5-positive relapsed or refractory T-cell malignancies who have limited options after standard treatments. This phase 1/2, multi-center, open-label, non-randomized study aims to find the best biological dose and assess safety, tolerability, and effectiveness of the therapy. The study enrolls up to 54 participants aged 1 to 70 years with specific T-cell cancers including acute lymphoblastic leukemia and other T-cell malignancies. Participants receive one of three types of CD5 CAR T-cell infusions after a lymphodepleting regimen: autologous cells from their own blood, donor cells from a previous stem-cell transplant donor, or cells from a newly matched donor. Dose levels are carefully adjusted based on a Bayesian optimal interval design, ranging from a low dose if cell numbers are limited to higher levels. The treatment is given once and closely monitored. During the study, participants will be followed for adverse events and dose-limiting toxicities within the first month after infusion. Response to treatment is assessed at around three months. Long-term monitoring for up to two years includes survival, disease progression, and pharmacokinetics of the CAR T cells. Participants undergo blood tests, bone marrow or cerebrospinal fluid analysis, and clinical evaluations to measure safety and treatment effects throughout the study period.
CONDITIONS
Brief Title
CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory CD5-positive T-cell malignancies with progression after standard therapies or intolerance to standard care
- Tumor burden in peripheral blood less than 20% for those receiving autologous CD5 CAR T cells
- Aged between 1 and 70 years
- No severe allergy
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Expected survival of at least 60 days
- CD5-positive blasts in bone marrow, cerebrospinal fluid, or tumor tissue confirmed by flow cytometry or immunohistochemistry
- Signed informed consent and ability to follow study procedures
- Available allogeneic stem cell donor and willingness to undergo transplantation if receiving newly matched donor-derived CD5 CAR T cells
You will not qualify if you...
- Impaired consciousness or intracranial hypertension
- Symptomatic congestive heart failure or severe arrhythmia
- Severe respiratory failure
- Other active malignancies
- Disseminated intravascular coagulation
- Elevated serum creatinine or blood urea nitrogen over 1.5 times the upper limit
- Sepsis or uncontrolled infections
- Uncontrolled diabetes
- Serious mental illness
- Active intracranial lesions on MRI
- Organ transplantation other than stem-cell transplantation
- Pregnancy
- Positive tests for hepatitis, AIDS, or syphilis
- Inability to undergo post-CAR stem cell transplantation if planned
- Inability to collect or lack of available peripheral blood mononuclear cells for CAR T manufacturing
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period prior to treatment infusion
Participants undergo a lymphodepleting regimen before receiving CD5 CAR T-cell infusion.
1 to 2 visits for lymphodepletion
Duration - Single infusion with follow-up monitoring
Participants receive CD5 CAR T-cell infusion depending on their assigned group: autologous, prior SCT donor-derived, or newly matched donor-derived.
1 infusion visit followed by frequent visits during first month
Duration - Up to 2 years
Participants are monitored for safety, adverse events, and treatment response for up to 2 years after infusion.
Regular follow-up visits during first 3 months, then periodic visits 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, 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
S
Shaocong Miao
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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