Actively Recruiting
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-13
10
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
N
Nanjing Bioheng Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
CONDITIONS
Official Title
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 70 years
- Diagnosis of relapsed or refractory natural killer/T cell lymphoma
- Positive expression of CD7 on lymphoma cells
- Bone marrow lymphoblasts 5% or more by morphology at screening
- Creatinine clearance at least 60 mL/min, ALT/AST less than 3 times upper limit of normal, total bilirubin less than 1.5 times upper limit of normal or 1.5 mg/dl or less
- Left ventricular ejection fraction 50% or higher
- Oxygen saturation at least 92% on room air
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated survival time more than 3 months
- Signed informed consent by participant or legal guardian
You will not qualify if you...
- Genetic syndromes linked to bone marrow failure
- Isolated extramedullary lesions
- Certain cardiac conditions
- Uncontrolled active central nervous system leukemia or grade CNS3 cerebrospinal fluid involvement
- History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, or hemorrhagic disease affecting compliance
- History of malignancy other than non-melanoma skin cancer or carcinoma
- Primary immune deficiency
- Presence of uncontrolled infections
- Previous anticancer therapy before CAR-T infusion
- Active uncontrolled acute infections
- Known HIV infection; active or latent hepatitis B, hepatitis C, or syphilis
- Receiving systemic steroid therapy prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
CONTACT
Y
Yinqiang Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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