Actively Recruiting
A Multicenter, Open-Label, Non-Randomized Study of Nanobody CD5-CAR T Cell Therapy for Relapsed or Refractory T Lymphocyte Malignancies
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
54
Participants Needed
4
Research Sites
N/A
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 anti-CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-cell malignancies who have limited treatment options. This multi-center, open-label, non-randomized phase 1/2 study aims to determine the optimal biological dose and assess the therapy's impact on cancer in these patients. The study includes three groups based on the source of the CAR T cells: autologous, previous stem-cell transplant donor-derived, or newly matched donor-derived cells. Participants will receive a lymphodepleting treatment followed by an infusion of CD5 CAR T cells from one of the three sources. The study will explore different doses, starting from 1 million cells per kilogram to 2 million cells per kilogram, with a lower dose option if cell production is insufficient. The trial involves a dose-finding phase (phase 1) to evaluate safety and a phase 2 to assess treatment response. Participants will be monitored closely for side effects and treatment response, with assessments including adverse event tracking up to two years and evaluation of tumor response at 3 months after infusion. Additional outcome measures include pharmacokinetics, progression-free survival, and overall survival. The total study duration includes monitoring for safety and effectiveness for up to two years after treatment infusion.
CONDITIONS
Brief Title
A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory CD5-positive T-cell malignancies after standard therapies or intolerance to standard care
- Tumor burden in peripheral blood less than 20% for those receiving autologous CD5 CAR T cells
- Age between 1 and 70 years
- No severe allergy history
- ECOG performance status score of 0 to 2
- Expected survival of at least 60 days
- CD5 positivity on blasts in bone marrow, cerebrospinal fluid, or tumor tissue by specified laboratory tests
- Signed informed consent and ability to follow study procedures
- Availability of allogeneic hematopoietic stem cell transplantation donor for those receiving newly matched donor-derived CD5 CAR T cells and willingness to undergo transplantation if complete remission is achieved
You will not qualify if you...
- Impaired consciousness or increased pressure in the skull
- Symptomatic congestive heart failure or severe heart rhythm problems
- Severe respiratory failure symptoms
- Presence of other malignancies
- Disseminated intravascular coagulation
- Elevated serum creatinine or blood urea nitrogen beyond 1.5 times the upper limit
- Uncontrolled infections like sepsis
- Uncontrollable diabetes
- Serious mental illness
- Active intracranial lesions seen on brain MRI
- History of organ transplantation except stem-cell transplantation
- Pregnancy
- Positive tests for hepatitis, AIDS, or syphilis infections
- Inability to undergo post-CAR stem cell transplantation if indicated
- Inability to collect or lack of available peripheral blood mononuclear cells for CAR T cell manufacturing
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 28 days after CD5 CAR T cell infusion
Participants receive a lymphodepleting regimen followed by infusion of CD5 CAR T-cells derived from autologous, previous stem-cell transplantation donor, or newly matched donor sources.
1 baseline visit and multiple follow-up visits during the first month
Duration - Up to 2 years after CD5 CAR T cell infusion
Participants are monitored for antitumor effects, safety, pharmacokinetics, and survival outcomes after CAR T-cell infusion.
Regular visits over 2 years for assessments
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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