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

NCT04723901 | Unknown Phase 1

• 1 other identifier: HEM-ONCO-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dual-target CAR-T Cells; B ALL; Relapse; Refractory B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

  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

  From date of initial treatment to the end of follow up, up to 2 years

Secondary Outcomes (1)

• Overall survival rate

  From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

Dual target CAR-T cell therapy

Biological: Dual target CAR-T cell therapy

Interventions

Dual target CAR-T cell therapy BIOLOGICAL

CD19/CD22 dual target CAR-T cell therapy

Treatment group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General hospital

Shenzhen, Guangdong, 518055, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shujiao he, Dr

CONTACT

+86-0755-21839178; he_shujiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: October 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)