RecruitingPhase 1NCT06732492
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Enrollment
10 participants
Start Date
Oct 31, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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。
Eligibility
Min Age: 3 YearsMax Age: 70 Years
Inclusion Criteria10
- Age 3-70
- Diagnosis of r/r NK/T lymphoma.
- CD7 positive expression
- Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
- Left ventricular ejection fraction ≥ 50% .
- Baseline oxygen saturation ≥ 92% on room air.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- The estimated survival time is more than 3 months.
- Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria12
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- Subjects with some cardiac conditions will be excluded.
- With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
- History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
- History of malignancy other than non-melanoma skin cancer or carcinoma.
- Primary immune deficiency.
- Presence of uncontrolled infections.
- Subjects with some anticancer therapy before CAR-T infusion will be excluded.
- Active uncontrolled acute infections.
- Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
- Subjects who are receiving systemic steroid therapy prior to screening.
Interventions
DRUGRD13-02 cell infusion
CAR-T cells
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06732492
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