NCT04439721

Brief Summary

Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

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
5

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2020

Shorter than P25 for early_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

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

June 16, 2020

Last Update Submit

January 4, 2021

Conditions

Leukemia, B-cell

Keywords

γδTleukemia

Outcome Measures

Primary Outcomes (2)

  • Identification of the dose limiting toxicity (DLT)

    Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.

    4 weeks after γδT infusion

  • The incidence of serious adverse events (SAEs)

    The incidence of serious adverse events (SAEs) after γδT infusion

    4 weeks after γδT infusion

Secondary Outcomes (3)

  • Disease-free survival time(DFS)

    about 2 years after γδT infusion

  • Overall survival (OS)

    about 2 years after γδT infusion

  • Duration of remission after administration (DOR)

    about 2 years after γδT infusion

Study Arms (1)

γδT

EXPERIMENTAL

γδT,Infusion,iv,0.5×10\^6-8×10\^7γδT /kg,once.

Drug: γδT Cell infusion agent

Interventions

γδT Cell infusion agentDRUG

γδT

γδT

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute leukemia patients undergoing salvage allogeneic hematopoietic stem cell transplantation
  • Age 10-65,Any gender
  • Expected lifetime\>3months
  • ECOG 0-2
  • DSA Negative
  • Successful granulocyte implantation
  • Liver and kidney function, heart and lung function meet the following requirements:①Creatinine≤1.5 ULN；②ALT/AST ≤5 ULN； ③Baseline oxygen saturation≥92%； ④Left ventricular ejection fraction≥50%
  • Female subjects with fertility who had a negative pregnancy test within 48 hours before the infusion and were not breastfeeding; all subjects with fertility potential before enrolling in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures
  • Signing informed consent patients must be able to understand and be willing to participate in this study, and sign informed consent at the same time

You may not qualify if:

  • Donor HBsAg or HBcAb positive and HBV DNA titer test is not within the normal reference value; donor or patient HCV antibody positive and peripheral blood HCV RNA positive; donor or patient HIV antibody positive; donor syphilis test positive
  • Active central nervous system disease
  • BMI index\>35
  • Allergic to DMSO
  • Graft-versus-host disease
  • Septic shock
  • Systemic steroid therapy is required during cell infusion or cell collection, or there are conditions that researchers believe may require steroid therapy during blood collection or during infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone are also allowed for physiological replacement therapy in patients with adrenal insufficiency
  • Participated in another clinical trial within 4 weeks before enrolling in the study, or intend to participate in another clinical trial throughout the study
  • According to the judgment of the investigator, it does not meet the situation of cell preparation
  • Circumstances considered by other researchers to be inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.188 Shizi Street

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-CellLeukemia

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Suning Chen, Ph.D

    Hematology，The First Affiliaated Hospital Of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suning Chen, Ph.D

CONTACT

13814881746chensuning@sina.com

Xiaofei Yang, Ph.D

CONTACT

18962156841yangxiaofei1977@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

CN(1)