Actively Recruiting
A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
54
Participants Needed
4
Research Sites
77 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
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...
- Patients with relapsed or refractory CD5-positive T-cell malignancies who have progressed after all standard treatments or cannot tolerate standard care
- Tumor burden in peripheral blood less than 20% for those who received autologous CD5 CAR T cells, and have paused anti-cancer treatment for more than 2 weeks
- Aged between 1 and 70 years
- No severe allergies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected to live at least 60 days
- CD5-positive cells in bone marrow or cerebrospinal fluid and tumor tissues by specified testing methods
- Signed informed consent and willingness to follow study procedures
- Availability of allogeneic stem cell donor and willingness to undergo transplantation if receiving newly matched donor CD5 CAR T cells and achieving complete remission
You will not qualify if you...
- Impaired consciousness or increased pressure inside the skull
- Symptomatic congestive heart failure or severe irregular heartbeat
- Severe respiratory failure
- Having other cancers
- Disseminated intravascular coagulation
- Elevated kidney function tests (creatinine or blood urea nitrogen 1.5 times above normal)
- Sepsis or uncontrolled infections
- Uncontrolled diabetes
- Serious mental illness
- Active brain lesions seen on MRI
- Prior organ transplantation except stem-cell transplantation
- Pregnancy
- Positive tests for hepatitis, AIDS, or syphilis
- Inability to undergo stem cell transplantation after CAR T cell therapy if newly matched donor cells are used
- Inability to collect or lack of stored cells for CAR T cell manufacturing
AI-Screening
AI-Powered Screening
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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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