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

Phase 1

• Conditions: Refractory B Acute Lymphoblastic Leukemia; Dual-target CAR-T Cells; B ALL; Relapse
• Interventions: Biological: Dual target CAR-T cell therapy

• Registration Number: NCT04723901
• Lead Sponsor: Shenzhen University General Hospital

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.

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 Timeline

• Study Start: 2020-10-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-23
• Last Update Submitted: 2021-01-23
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Dual target CAR-T cell therapy	Dual target CAR-T cell therapy

Primary Outcome Measures

Name	Time	Method
Complete remission rate	From date of initial treatment to the end of follow up, up to 2 years	1. No blasts in peripheral blood, no extramedullary leukemia; 2. Three-line bone marrow hematopoietic recovery, primitive cells \<5%; 3. Peripheral blood absolute neutrophil count\>1.0×10\^9/L; 4. Peripheral blood platelet count\>100×10\^9/L; 5. No recurrence within 4 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shenzhen University General hospital; 🇨🇳 Shenzhen, Guangdong, China