Clinical trial NCT04723901: Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia
Official title: Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dual-target CAR-T Cells
B ALL
Relapse
Refractory B Acute Lymphoblastic Leukemia
Lead sponsor: Shenzhen University General Hospital
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete remission rate
timeFrame: From date of initial treatment to the end of follow up, up to 2 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: From admission to the end of follow up, up to 2 years.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen University General hospital
state: Guangdong
Study officials:
affiliation: Shenzhen University General Hospital
name: Li Yu, Dr
role: PRINCIPAL_INVESTIGATOR
References: