Cell injection for patients with relapsed or refractory CD7-positive NK/T cell malignancies

RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies

This study is testing a new cell therapy for people with hard-to-treat CD7-positive NK/T cell lymphoma to see if it is safe and helps improve their condition.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 3 Years to 70 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06732492 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, phase I clinical trial that aims to evaluate the safety and pharmacokinetics of CD7 Chimeric Antigen Receptor-T (CAR-T) therapy in patients diagnosed with CD7-positive relapsed or refractory natural killer/T cell lymphoma. The study will involve the infusion of RD13-02 cells into eligible participants, who will be monitored for safety and treatment response. The trial is conducted at a single center, focusing on a specific patient population with a challenging malignancy.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 3-70 with a diagnosis of relapsed or refractory NK/T lymphoma who express CD7.

Not a fit: Patients with isolated extramedullary lesions or certain cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat CD7-positive NK/T cell malignancies.

How similar studies have performed: While this approach is novel for CD7-positive NK/T cell malignancies, similar CAR-T therapies have shown promise in other hematologic malignancies.

Eligibility criteria

Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r NK/T lymphoma.
3. CD7 positive expression
4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
5. 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
6. Left ventricular ejection fraction ≥ 50% .
7. Baseline oxygen saturation ≥ 92% on room air.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
9. The estimated survival time is more than 3 months.
10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
2. Isolated extramedullary lesions
3. Subjects with some cardiac conditions will be excluded.
4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
5. 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.
6. History of malignancy other than non-melanoma skin cancer or carcinoma.
7. Primary immune deficiency.
8. Presence of uncontrolled infections.
9. Subjects with some anticancer therapy before CAR-T infusion will be excluded.
10. Active uncontrolled acute infections.
11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
12. Subjects who are receiving systemic steroid therapy prior to screening.

Where this trial is running

Wuhan, Hubei

• Union Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Heng Mei, Ph.D&M.D

Conditions NK T-Cell Lymphoma; CART Therapy; CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies