Actively Recruiting
CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
54
Participants Needed
4
Research Sites
132 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
This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.
CONDITIONS
Official 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...
- Patients with relapsed or refractory CD5-positive T-cell malignancies who have progressed after all standard therapies or are intolerant to standard care
- Tumor burden in peripheral blood less than 20% for patients who received autologous CD5 CAR T cells and no anti-neoplastic treatment for more than 2 weeks
- Aged between 1 and 70 years
- No severe allergy
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Expected to live at least 60 days
- CD5 positivity on blasts in bone marrow or cerebrospinal fluid and tumor tissues confirmed by flow cytometry or immunohistochemistry
- Signed informed consent obtained from participant or legal guardian as appropriate
- Availability of allogeneic hematopoietic stem cell transplantation donor for patients receiving newly matched donor-derived CD5 CAR T cells and willingness to undergo SCT if remission is achieved
You will not qualify if you...
- Impaired consciousness or intracranial hypertension
- Symptomatic congestive heart failure or severe cardiac arrhythmia
- Severe respiratory system failure
- Presence of other malignancies
- Disseminated intravascular coagulation
- Serum creatinine or blood urea nitrogen levels 1.5 times or more above the upper limit
- Sepsis or uncontrolled infections
- Uncontrolled diabetes
- Serious mental illness
- Active intracranial lesions on brain MRI
- Prior organ transplantation except stem cell transplantation
- Pregnancy
- Positive test for infectious hepatitis, AIDS, or syphilis
- Infeasibility of post-CAR stem cell transplantation for patients receiving newly matched donor CD5 CAR T cells
- Inability to collect peripheral blood mononuclear cells or lack of frozen samples for CAR T cell manufacturing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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