Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia

Sponsor

Shenzhen University General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04723901

Collaborator

(none)

Enrollment

Location

Arm

26.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Dual-target CAR-T Cells B ALL Relapse Refractory B Acute Lymphoblastic Leukemia	Biological: Dual target CAR-T cell therapy	Phase 1/Phase 2

Detailed Description

Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD22 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Actual Study Start Date :

Oct 20, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Dual target CAR-T cell therapy	Biological: Dual target CAR-T cell therapy CD19/CD22 dual target CAR-T cell therapy

Arm

Intervention/Treatment

Experimental: Treatment group

Dual target CAR-T cell therapy

Biological: Dual target CAR-T cell therapy

CD19/CD22 dual target CAR-T cell therapy

Outcome Measures

Primary Outcome Measures

Complete remission rate [From date of initial treatment to the end of follow up, up to 2 years]
No blasts in peripheral blood, no extramedullary leukemia; Three-line bone marrow hematopoietic recovery, primitive cells <5%; Peripheral blood absolute neutrophil count>1.0×10^9/L; Peripheral blood platelet count>100×10^9/L; No recurrence within 4 weeks

Secondary Outcome Measures

Overall survival rate [From admission to the end of follow up, up to 2 years.]
The proportion of surviving patients at the end of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:

14-75 years old, no gender limit;
According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL);
ECOG behavior status score is 0-2 points;
Expected survival time ≥ 3 months;
No contraindications to peripheral apheresis;
Flow cytometry confirms that the original cells express CD22;
Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
No serious heart, lung, liver or kidney disease;
Ability to understand and willing to sign the informed consent form for this trial.

Exclusion Criteria:

Patients with any of the following cannot be included in this study:

The original cells expressing CD19 and CD22 are negative;
There is active infection;
Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
HIV/AIDS patients;
Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
Known or suspected drug abuse or alcohol dependence;
People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
Those who have participated in other clinical trials within 30 days;
Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
The investigator judged that it is not suitable to participate in this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen University General hospital	Shenzhen	Guangdong	China	518055

Sponsors and Collaborators

Shenzhen University General Hospital

Investigators

Principal Investigator: Li Yu, Dr, Shenzhen University General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

YuLi, Professor, Shenzhen University General Hospital

ClinicalTrials.gov Identifier:

NCT04723901

Other Study ID Numbers:

HEM-ONCO-005

First Posted:

Jan 26, 2021

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Study Results

No Results Posted as of Jan 26, 2021