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

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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory B Acute Lymphoblastic Leukemia; Relapse; B ALL; Dual-target CAR-T Cells
• Intervention / Treatment: Biological: Dual target CAR-T cell therapy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518055
      • Recruiting
      • Shenzhen University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shenzhen University General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: HEM-ONCO-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no intention

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No