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New treatment option for NK T-Cell Lymphoma
Official title RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
ClinicalTrials.gov ID: NCT06732492
What this study is testing
What is RD13-02 cell infusion?
RD13-02 cell infusion is an investigational medicine, being studied as a potential treatment for nk t-cell lymphoma.
Also referred to as universal CD7 CAR-T cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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。
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 70
You may be able to join if
- 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...
You likely can't join if
- people with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- people 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...
- History of malignancy other than non-melanoma skin cancer or carcinoma.
See the full eligibility 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...
- 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.
- people or their legal guardians volunteer to participate in the study and sign the informed consent.
- people with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- people 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...
- History of malignancy other than non-melanoma skin cancer or carcinoma.
- Primary immune deficiency.
- Presence of uncontrolled infections.
- people 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.
- people who are receiving systemic steroid therapy prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.