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RecruitingNCT06732492Updated Dec 13, 2024

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

A Phase 1 interventional study of RD13-02 cell infusion in NK T-Cell Lymphoma, CART Therapy and CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies, sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by Wuhan Union Hospital, China · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
3 Years to 70 Years
Sex
All
01

Study 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。

02

Conditions studied

  • NK T-Cell Lymphoma
  • CART Therapy
  • CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
03

In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    RD13-02 cell infusion

    RD13-02 cells targeting CD7 were injected intravenously

    Drug: RD13-02 cell infusion

Interventions

  • DrugRD13-02 cell infusion

    CAR-T cells

    Also known as: universal CD7 CAR-T cells

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

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

    Time frame: Evaluate at 4 weeks after CAR-T infusion

Secondary outcomes

  1. Duration of remission (DOR)

    The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion

    Time frame: Up to 1 years after CAR-T infusion

  2. Event-free survival (EFS)

    The time from first achieving CR/CRi to relapse or death

    Time frame: Up to 1 years after CAR-T infusion

  3. Overall survival (OS)

    The time from CAR-T infusion to death due to any cause

    Time frame: Up to 1 years after CAR-T infusion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06732492
Lead sponsor
Wuhan Union Hospital, China
Collaborators
Nanjing Bioheng Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Dec 13, 2024
Start date
Oct 31, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Dec 13, 2024

Study contacts

Heng Mei, Ph.D&M.D
Contact
hmei@hust.edu.cn
027-8572600
Yinqiang Zhang
Contact
zhang_yq@hust.edu.cn
15007101371

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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