Recruiting NCT06732492
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RD13-02 cell infusion.
- Who it may be relevant to
- Registry conditions: NK T-Cell Lymphoma, CART Therapy, CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies. Basic parameters: 3 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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。
Interventions
- Drug RD13-02 cell infusion
CAR-T cells
Primary outcome measures
- Overall response rate (ORR) [Time frame: Evaluate at 4 weeks after CAR-T infusion]
Secondary outcome measures (3)
- Duration of remission (DOR) [Time frame: Up to 1 years after CAR-T infusion]
- Event-free survival (EFS) [Time frame: Up to 1 years after CAR-T infusion]
- Overall survival (OS) [Time frame: Up to 1 years after CAR-T infusion]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital — Wuhan
Identifiers
NCT: NCT06732492 · WHUH-RD13-02-01