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RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06732492•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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

Age

3 - 70 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

Union Hospital

Wuhan, Hubei, China

Key Dates

Start Date

October 31, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

December 13, 2024

Enrollment

ESTIMATED participants

Conditions

NK T-Cell LymphomaCART TherapyCD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

Interventions

RD13-02 cell infusion

DRUG

Contacts

Heng Mei, Ph.D&M.D

CONTACT

027-8572600 hmei@hust.edu.cn

Yinqiang Zhang

CONTACT

15007101371 zhang_yq@hust.edu.cn