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INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia

NCT06209671 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-17

No results posted yet for this study

Summary

This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia

Conditions

  • Leukemia, B-cell

Interventions

BIOLOGICAL

INS19 CAR-T Cells

INS19 CAR-T Cells, 1-2×10\^7 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Beijing Immunochina Medical Science & Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiangyu Zhao, PhD · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-01-15
Completion
2026-01-15

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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 NCT06209671 on ClinicalTrials.gov