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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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。

Eligibility criteria

Qualifiers

Age 3-70

Diagnosis of r/r NK/T lymphoma.

CD7 positive expression

Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • RD13-02 cell infusion

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators