NCT04762485

Brief Summary

This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

June 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

February 8, 2021

Last Update Submit

June 1, 2021

Conditions

T Lymphoblastic Leukemia/LymphomaMixed Phenotype Acute LeukemiaAcute Myeloid Leukemia

Keywords

CD7 PositiveCAR-T

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    Adverse events are evaluated with CTCAE V5.0

    12 months

Secondary Outcomes (3)

  • Overall response rate (ORR)

    2 years

  • Cumulative incidence of relapse(CIR)

    2 years

  • the duration of CAR T-cells in vivo

    2 years

Study Arms (1)

CD38 positive relapsed or refractory acute leukemia

EXPERIMENTAL

Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5- 10)x10\^6 CD7 CAR-T cells/kg

Biological: Humanized CD7 CAR-T cells

Interventions

Humanized CD7 CAR-T cellsBIOLOGICAL

Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5-10)x10\^6 CD7 CAR-T cells/kg

CD38 positive relapsed or refractory acute leukemia

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed CD7 positive relapsed/refractory acute leukemia.
  • Age 12-65 years.
  • Eastern Cooperative Oncology Group (ECOG) score 0-2.
  • CD7 on leukemia is \>30% positive detected with flow cytometry.
  • Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
  • Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.

You may not qualify if:

  • Patients are pregnant or lactating
  • Patients with congenital immunodeficiency.
  • Patients with central nervous system leukemia.
  • Patients with uncontrolled active infection.
  • Patients with active hepatitis B or hepatitis C infection.
  • Patients with HIV infection.
  • Patients with atrial or venous thrombosis or embolism.
  • Patients with myo-infarction or severe arrythmia in the recent 6 months.
  • Other comorbidities that investigators considered not suitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, (Select), 215000, China

RECRUITING

Related Publications (1)

  • Cao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6.

    PMID: 36175988DERIVED

MeSH Terms

Conditions

LymphomaLeukemia, Biphenotypic, AcuteLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, Myeloid

Study Officials

  • xiaowen tang, Ph.D

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaowen tang, Ph.D

CONTACT

(0086)51267781856xwtang1020@163.com

Lin Yang, Ph.D

CONTACT

(0086)18896802149ylyh188@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 21, 2021

Study Start

June 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2024

Last Updated

June 2, 2021

Record last verified: 2021-01

Locations

CN(1)