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CompletedNCT05902845Updated Nov 21, 2024

RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL

An Early Phase 1 interventional study of RD13-02 cell infusion in Neoplasms, Hematologic Neoplasms and Hematologic Diseases, sponsored by Xiaoyu Zhu. Completed at 1 site in China. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Xiaoyu Zhu · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
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 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.

02

Conditions studied

  • Neoplasms
  • Hematologic Neoplasms
  • Hematologic Diseases
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 4 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Xiaoyu Zhu as lead sponsor.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 3-70
  2. Diagnosis of r/r T-ALL/LBL.
  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. 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. Sujects with concomitant genetic syndromes associated with bone marrow failure states.
  2. Sujects with some cardiac conditions will be excluded.
  3. 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.
  4. History of malignancy other than non-melanoma skin cancer or carcinoma.
  5. Primary immune deficiency.
  6. Presence of uncontrolled infections.
  7. Sujects with some anticancer therapy before CAR-T infusion will be excluded.
  8. Active uncontrolled acute infections.
  9. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
  10. Subjects who are receiving systemic steroid therapy prior to screening.
  11. Subjects with acute graft-versus-host disease (GvHD)
  12. Having received live/attenuated vaccine within 4 weeks prior to screening.
  13. History of allergy to any component of the cell therapy product.
  14. Pregnant or breastfeeding women
  15. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
05

Study design

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

Study arms

  • Experimental
    RD13-02 cell infusion

    drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection dosage : 2×10\^8 CAR+ T cells frequency : Once

    Drug: RD13-02 cell infusion

Interventions

06

What researchers measure

Primary outcomes

  1. Overall response rate, ORR

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

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

  2. Overall response rate, ORR

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

    Time frame: Evaluate at 8 weeks after CAR-T infusion

  3. Overall response rate, ORR

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

    Time frame: Evaluate at 12 weeks after CAR-T infusion

Secondary outcomes

  1. Overall response rate with MRD-negative, MRD-ORR

    Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow

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

  2. 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

  3. 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

  4. The proportion of patients who receive hematopoietic stem cell transplantation

    The proportion of subjects who achieved remission after infusion who received HSCT.

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

  5. 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 site
  • The First Affiliated Hospital of University of Science and Technology of China
    Hefei, Anhui 230002, China
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 Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05902845
Lead sponsor
Xiaoyu Zhu
Collaborators
Nanjing Bioheng Biotech Co., Ltd.
Responsible party
Xiaoyu Zhu (Clinical Professor, Anhui Provincial Hospital) — Sponsor-investigator
First posted
Jun 15, 2023
Start date
Apr 30, 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024
Last update
Nov 21, 2024

Oversight

Data monitoring committee
Yes
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 Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Anti-CD7 CAR-T Cells RD13-02

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