NCT06732492RecruitingPhase 1
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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。
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 10 Dec 2024
- Start date
- 31 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Childhood cancers
- NCT number
- NCT06732492
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 31 Oct 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Subjects with some anticancer therapy before CAR-T infusion will be excluded.
- Subjects who are receiving systemic steroid therapy prior to screening.
Other illness
- Subjects with some cardiac conditions will be excluded.
- 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.
- Presence of uncontrolled infections.
- Active uncontrolled acute infections.
- Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
Other
- Isolated extramedullary lesions
- With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
- Primary immune deficiency.
Who the study is looking for
- 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.
Age in the registry: 3 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.