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

NCT06732492 | Recruiting Phase 1

• 1 other identifier: WHUH-RD13-02-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)

  Evaluate at 4 weeks after CAR-T infusion

Secondary Outcomes (3)

• Duration of remission (DOR)

  Up to 1 years after CAR-T infusion

• Event-free survival (EFS)

  Up to 1 years after CAR-T infusion

• Overall survival (OS)

  Up to 1 years after CAR-T infusion

Study Arms (1)

RD13-02 cell infusion

EXPERIMENTAL

RD13-02 cells targeting CD7 were injected intravenously

Drug: RD13-02 cell infusion

Interventions

RD13-02 cell infusion DRUG

CAR-T cells

Also known as: universal CD7 CAR-T cells

RD13-02 cell infusion

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• Primary immune deficiency.
• Presence of uncontrolled infections.
• Subjects with some anticancer therapy before CAR-T infusion will be excluded.
• Active uncontrolled acute infections.
• Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
• Subjects who are receiving systemic steroid therapy prior to screening.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Heng Mei, Ph.D&M.D

CONTACT

027-8572600; hmei@hust.edu.cn

Yinqiang Zhang

CONTACT

15007101371; zhang_yq@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)