MedTrace Logo

Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer

NCT05211557 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-01-27

No results posted yet for this study

Summary

This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.

Conditions

Interventions

BIOLOGICAL

fhB7H3.CAR-Ts

Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated. Other Name: B7H3 targeting chimeric antigen receptor T cells Drug: Fludarabine 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3) Other Name: FLUDARA Drug: Cyclophosphamide 750 mg/m2 i.v. for once (Day -5) Other Name: Cytoxan

Sponsors & Collaborators

  • Xuzhou Medical University

    collaborator OTHER

  • IIT MediTech (Jiangsu) Co. Ltd

    collaborator UNKNOWN

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Junnian Zheng, M.D., Ph.D. · The Affiliated Hospital of Xuzhou Medical University, Xuzhou Medical University

  • Longzhen Zhang, M.D., Ph.D. · The Affiliated Hospital of Xuzhou Medical University

  • Gang Wang, Ph.D. · Xuzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2023-08-31
Completion
2026-08-31

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 NCT05211557 on ClinicalTrials.gov