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CompletedNCT04538599Updated Jan 25, 2022

RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

A Phase 1 interventional study of RD13-01 cell infusion in Hematologic Malignancies, sponsored by He Huang. Completed at 1 site in China. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by He Huang · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
3 Years to 70 Years
Sex
All
01

Study summary

This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.

02

Conditions studied

  • Hematologic Malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

He Huang is the lead sponsor of 21 studies on the registry; 13 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. Aged 3 to 70 years.
  2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
  3. ECOG: 0-2.
  4. Life expectancy greater than 12 weeks.
  5. Cardiac left ventricle ejection fraction ≥50%.
  6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating.
  2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
  3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
  4. Participated in other clinical studies within 2 weeks prior to screening.
  5. History of alcoholism, drug abuse or mental illness.
  6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    RD13-01 cell infusion

    Drug: RD13-01 cell infusion

Interventions

  • DrugRD13-01 cell infusion

    Universal CAR-T cells targeting CD7

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: 4 weeks after infusion

07

Study locations

1 site
  • The First Affiliated Hospital，College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04538599
Lead sponsor
He Huang
Responsible party
He Huang (PhD, Zhejiang University) — Sponsor-investigator
First posted
Sep 4, 2020
Start date
Sep 10, 2020
Primary completion
Feb 17, 2021
Completion
Nov 30, 2021
Last update
Jan 25, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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