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
52 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
Researchers are evaluating the safety and behavior of CD7 Chimeric Antigen Receptor-T (CAR-T) therapy in patients who have CD7-positive relapsed or refractory natural killer/T cell lymphoma. This phase I study is conducted at a single center and aims primarily to assess safety and pharmacokinetics of the CAR-T cells in this patient group. The trial focuses on individuals aged 3 to 70 years with this specific lymphoma type that is difficult to treat with standard options. Participants receive an intravenous infusion of RD13-02 cells designed to target CD7. This study has a single treatment arm where all patients get the CAR-T cell infusion. The trial monitors the treatment effects and safety over time, with the main outcome measured four weeks after infusion. Secondary outcomes include tracking remission duration, event-free survival, and overall survival up to one year following the treatment. During the study, participants will be closely evaluated for treatment response and any side effects. Assessments include blood tests, heart function checks, oxygen levels, and performance status evaluations. Researchers also monitor survival and remission status for up to one year post-infusion. Participants or their guardians must provide informed consent, and ongoing follow-up ensures safety and gathers data on how well the CAR-T cells work in this lymphoma.
CONDITIONS
Brief 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
- Expression of CD7 on lymphoma cells
- Bone marrow lymphoblasts 5% or more at screening
- Adequate kidney function with creatinine clearance ≥ 60 mL/min
- Liver enzymes (ALT/AST) less than 3 times the upper limit of normal
- Total bilirubin less than 1.5 times the upper limit of normal or ≤ 1.5 mg/dl
- Left ventricular ejection fraction of 50% or greater
- Baseline oxygen saturation of 92% or higher on room air
- ECOG performance status between 0 and 2
- Estimated survival time of more than 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Genetic syndromes associated with bone marrow failure
- Isolated extramedullary lesions
- Certain cardiac conditions
- Uncontrolled active central nervous system leukemia or CNS grade 3
- History of traumatic brain injury, seizures, cerebrovascular disease affecting compliance
- History of other malignancies except non-melanoma skin cancer or carcinoma
- Primary immune deficiency
- Presence of uncontrolled infections
- Prior anticancer therapy before CAR-T infusion
- Active uncontrolled acute infections
- Known infection with HIV, active or latent hepatitis B or C, or syphilis
- Use of systemic steroid therapy before screening
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 1 year after infusion
Participants receive RD13-02 cell infusion targeting CD7 intravenously as the active treatment.
1 baseline infusion visit and multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
Y
Yinqiang Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here