NCT04599556

Brief Summary

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

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
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2021

Longer than P75 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

October 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

October 21, 2020

Last Update Submit

November 29, 2023

Conditions

CD7+ Acute LeukemiaCD7+ Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicity

    28 days

  • Treatment Emergent Adverse Event

    2 years

Study Arms (3)

T-ALL/LBL

EXPERIMENTAL
Biological: anti-CD7 CAR-T

T-NHL

EXPERIMENTAL
Biological: anti-CD7 CAR-T

AML

EXPERIMENTAL
Biological: anti-CD7 CAR-T

Interventions

anti-CD7 CAR-TBIOLOGICAL

Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

AMLT-ALL/LBLT-NHL

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
  • Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
  • The estimated survival time is more than 3 months;
  • ECOG score was 0-2;
  • The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
  • For T-ALL/LBL:
  • Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
  • The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
  • No CR was obtained by standard chemotherapy;
  • The first induction was CR, but the duration of CR was less than 12 months;
  • No CR was obtained after the first or multiple remedial treatment;
  • Relapse twice or more;
  • The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).
  • For T-NHL:
  • +14 more criteria

You may not qualify if:

  • Patients with history of epilepsy or other central nervous system diseases;
  • Patients with prolonged QT or severe heart disease;
  • Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
  • The patients with uncontrolled active infection;
  • Active hepatitis B or hepatitis C virus infection;
  • Previous application of gene therapy;
  • The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
  • Those who suffer from other uncontrolled diseases are not suitable to join the study;
  • HIV infection;
  • Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (2)

  • Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.

    PMID: 38657244DERIVED

  • Xu X, Zu C, Zhang M, Xiao P, Hong R, Feng J, Xu H, Cui J, Yu J, Shi J, Wei G, Chang AH, Huang H, Hu Y. HLA Fully-Mismatched Sibling-Derived CD7 CAR-T Therapy Bridging to Haploidentical Hematopoietic Stem Cell Transplantation for Hepatosplenic gammadelta T-cell Lymphoma. Cell Transplant. 2023 Jan-Dec;32:9636897231194265. doi: 10.1177/09636897231194265.

    PMID: 37667507DERIVED

Central Study Contacts

Yongxian Hu

CONTACT

+86-0571-87236476huyongxian2000@aliyun.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 22, 2020

Study Start

April 1, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2025

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)