NCT04594135

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or 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 Dec 2020

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

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

October 14, 2020

Last Update Submit

February 27, 2021

Conditions

T-cell Acute Lymphoblastic LeukemiaT-cell Non-Hodgkin Lymphoma

Keywords

anti-CD5 CART cell leukemia/lymphomaT-ALL

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events after anti-CD5 CAR T cells cell infusion

    Determine the toxicity profile of anti-CD5 CAR T cell therapy

    2 years particularly the first 28 days after infusion

Secondary Outcomes (4)

  • Incidence of treatment-emergent adverse events

    up to 6 months

  • Disease Free Survival (DFS)

    up to 2 years

  • Progression-Free Survival (PFS)

    up to 2 years

  • Overall Survival (OS)

    up to 2 years

Study Arms (1)

anti-CD5 CAR T cells

EXPERIMENTAL

Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg

Drug: anti-CD5 CAR T cells

Interventions

anti-CD5 CAR T cellsDRUG

anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells

anti-CD5 CAR T cells

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent; Patients volunteer to participate in the research
  • Diagnosis is mainly based on the World Health Organization (WHO) 2008
  • Patients have exhausted standard therapeutic options
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
  • Female must be not pregnant during the study

You may not qualify if:

  • Patients declining to consent for treatment
  • Prior solid organ transplantation
  • Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  • Any drug used for GVHD must be stopped \>1 week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-CellLeukemia, T-CellLymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Hongyu Zhang, MD/PhD

    Peking University Shenzhen Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin G Pinz, MS

CONTACT

6315386218kevin.pinz@icellgene.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

December 1, 2020

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)