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

Relapse Clinical Trial

— CAR-T  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723901
• Other study ID #: HEM-ONCO-005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 20, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: Shenzhen University General Hospital
• Contact: shujiao he, Dr
• Phone: +86-0755-21839178
• Email: he_shujiao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

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

1. 14-75 years old, no gender limit;

2. 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);

3. ECOG behavior status score is 0-2 points;

4. Expected survival time = 3 months;

5. No contraindications to peripheral apheresis;

6. Flow cytometry confirms that the original cells express CD22;

7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;

8. No serious heart, lung, liver or kidney disease;

9. 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:

1. The original cells expressing CD19 and CD22 are negative;

2. There is active infection;

3. Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);

4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;

5. HIV/AIDS patients;

6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;

7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);

8. Known or suspected drug abuse or alcohol dependence;

9. 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;

10. Those who have participated in other clinical trials within 30 days;

11. 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);

12. The investigator judged that it is not suitable to participate in this trial.

Related Conditions & MeSH terms

• B ALL
• Dual-target CAR-T Cells
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Relapse

Intervention

Biological:
• Dual target CAR-T cell therapy
CD19/CD22 dual target CAR-T cell therapy

Locations

Country	Name	City	State
China	Shenzhen University General hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	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	From date of initial treatment to the end of follow up, up to 2 years
Secondary	Overall survival rate	The proportion of surviving patients at the end of the study.	From admission to the end of follow up, up to 2 years.