NCT04823091

Brief Summary

This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refractory T lymphoid malignancies.

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
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 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

March 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2024

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 29, 2021

Last Update Submit

March 1, 2022

Conditions

T-Cell Lymphocytic LeukemiaT-Cell Chronic Lymphocytic LeukemiaT Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-related Adverse Events

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    within 2 years after infusion

Secondary Outcomes (5)

  • Overall response rate(ORR) of administering CAR7-T cells in Relapsed/Refractory CD7+ T-cell hematological malignancies.

    within 2 years after infusion

  • Complete response rate(CRR) of administering CAR7-T cells in Relapsed/Refractory CD7+ T-cell hematological malignancies.

    within 2 years after infusion

  • Progress-free survival(PFS) of administering CAR7-T cells in Relapsed/Refractory CD7+ T-cell hematological malignancies.

    within 2 years after infusion

  • Duration of Response(DOR) of administering CAR7-T cells in Relapsed/Refractory CD7+ T-cell hematological malignancies.

    within 2 years after infusion

  • Overall survival(OS) of administering CAR7-T cells in Relapsed/Refractory CD7+ T-cell hematological malignancies.

    within 2 years after infusion

Other Outcomes (1)

  • In vivo expansion and survival of CAR7-T cells

    within 2 years after infusion

Study Arms (1)

Fludarabine + Cyclophosphamide + anti-CD7 CAR-T Cells

EXPERIMENTAL

Patients will received lymphodepletion with fludarabine (30 mg/kg) and cyclophosphamide (250 mg/kg) on day -5, -4, and -3, followed by the infusion of CAR7-T cells with the dose of 1×10\^6/kg and 2×10\^6/kg (with an allowance of ±20%). If no dose-limited toxicity (DLT) emerges in the group, then the subsequent higher dose will be used in the next group. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level. The maximum dose could be extended.

Drug: Fludarabine + Cyclophosphamide + CAR7-T Cells

Interventions

Fludarabine + Cyclophosphamide + CAR7-T CellsDRUG

fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 250 mg/kg on day -5, -4, and -3; CAR7-T Cells on day 0.

Fludarabine + Cyclophosphamide + anti-CD7 CAR-T Cells

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 14 to 70 years;
  • Expected survival over 60 days;
  • Eastern Cooperative Oncology Group score 0-2;
  • Diagnosed as T-cell hematologic malignancies (including leukemia and lymphoma) according to WHO2016 criteria;
  • Patients must relapse or be refractory after at least two lines of therapy.
  • CD7 were positive in bone marrow or cerebrospinal fluid by immunohistochemistry or flow cytometry at screening, and one of the following conditions is satisfied:
  • A. No remission was achieved after at least 2 lines of standard therapy; B. Relapse or progression after standard treatment; C. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
  • Have no fertility requirements or plans for one year since enrollment in this clinical trial;
  • Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.

You may not qualify if:

  • Complicated with central system leukemia/lymphoma with active intracranial lesions;
  • Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune disease;
  • Symptomatic heart failure or severe arrhythmias;
  • Symptoms of severe respiratory failure;
  • Complicated with other types of malignant tumors;
  • Serum creatinine and/or urea nitrogen ≥ 1.5 times of normal value;
  • Suffer from sepsis or other uncontrollable infections;
  • Intracranial hypertension or brain consciousness disorder;
  • Severe mental disorders;
  • Have received organ transplantation (excluding bone marrow transplantation);
  • Female patients (fertile patients) had positive blood HCG test;
  • Hepatitis (including hepatitis B and C), AIDS and syphilis were screened positive;
  • Patients with graft-versus-host disease (GVHD) or who require immunosuppressant treatment;
  • The absolute value of lymphocytes was too low to manufacture CART cells;
  • Other conditions considered inappropriate by the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (1)

  • Gomes-Silva D, Srinivasan M, Sharma S, Lee CM, Wagner DL, Davis TH, Rouce RH, Bao G, Brenner MK, Mamonkin M. CD7-edited T cells expressing a CD7-specific CAR for the therapy of T-cell malignancies. Blood. 2017 Jul 20;130(3):285-296. doi: 10.1182/blood-2017-01-761320. Epub 2017 May 24.

    PMID: 28539325BACKGROUND

MeSH Terms

Conditions

Leukemia, T-CellLeukemia, Prolymphocytic, T-CellLymphoma, T-Cell

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, ProlymphocyticLymphoma, Non-HodgkinLymphoma

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Heng Mei

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng Mei

CONTACT

027-8572600hmei@hust.edu.cn

Chenggong Li

CONTACT

18868112136chenggongli@hust.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proferssor, Cheif Doctor

Study Record Dates

First Submitted

March 29, 2021

First Posted

March 30, 2021

Study Start

April 15, 2021

Primary Completion

April 7, 2023

Study Completion

April 7, 2024

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)