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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Union Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Heng Mei, Ph.D&M.D
• Email: hmei@hust.edu.cn
• Phone: 027-8572600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cognitive changes after BCMA CAR-T in multiple myeloma

  This study tests whether cognitive function changes over time in adults with relapsed or refractory multiple myeloma who receive BCMA CAR-T therapy.

  Recruiting Wake Forest University Health Sciences · Charlotte, North Carolina · NCT07740317

• Geriatric assessment before CAR‑T or bispecific antibody therapy to predict side effects and outcomes in older adults

  This study will test whether a brief geriatric assessment done before CAR‑T or bispecific antibody treatment can help predict side effects and outcomes for people aged 65 and older with aggressive lymphoma or multiple myeloma.

  Recruiting at 2 sites University of Zurich · Bern and 1 other locations · NCT07309497

• Early versus late stopping of antibiotics for adults with high‑risk blood cancers or after stem‑cell or CAR T therapy who develop fever

  This trial tests if stopping antibiotics early is safe for adults with leukemia or after stem‑cell transplant or CAR T therapy when a fever has settled.

  Recruiting at 2 sites Peter MacCallum Cancer Centre, Australia · Melbourne, Victoria and 1 other locations · NCT07051525

• Comparing immunotherapy bridging treatment to standard therapy in low-risk B-NHL patients

  This study is testing whether adding an immunotherapy treatment with zanubrutinib helps people with low-risk B-cell non-Hodgkin lymphoma feel better compared to those who don’t get this extra treatment.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT06695013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.