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KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

NCT07246707 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-24

No results posted yet for this study

Summary

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

Conditions

  • B-ALL

Interventions

DRUG

KSV01 Injection

KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector.

Sponsors & Collaborators

  • TCRx Therapeutics Co.Ltd

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Principal Investigators

  • He Huang, MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-10-31
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246707 on ClinicalTrials.gov