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Safety and Efficacy Study of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

NCT05266950 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-11-14

No results posted yet for this study

Summary

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and efficacy of CI-135 CAR-T cells in subjects with relapsed or refractory Acute Lymphoblastic Leukemia. This study is a dose-escalation study that includes 2 dose levels, and a total of 4-7 subjects will be enrolled. CI-135 CAR-T cells will be manufactured using PBMC collected from the subjects, and will be infused intravenously into subjects after lymphodepletion.

Conditions

Interventions

BIOLOGICAL

CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)

Recommended lymphodepletion regimen: cyclophosphamide (250 mg/m2/d, ×3d) and fludarabine (30 mg/m2/d, ×3d). If the patient has a hematological toxicity of grade 3 or higher, the alternative regimen is: cyclophosphamide (125mg/m2/d, ×3d) and fludarabine (15 mg/m2/d, ×3d). During lymphodepletion, physicians can give anti-myeloid drugs such as demethoxydaunorubicin or daunorubicin as appropriate.

Sponsors & Collaborators

  • Beijing Boren Hospital

    lead OTHER

Principal Investigators

  • Jing Pan, MD/PhD · Beijing Gaobo Boren Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2023-12-12
Completion
2023-12-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05266950 on ClinicalTrials.gov