Safety and Efficacy of CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma

Last updated: April 16, 2023
Sponsor: Chongqing Precision Biotech Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Leukemia

Chronic Lymphocytic Leukemia

Treatment

N/A

Clinical Study ID

NCT04648475
PBC019
  • Ages 3-75
  • All Genders

Study Summary

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent;
  2. Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of thefollowing conditions:
  3. Failed to standard chemotherapy regimens;
  4. Relapse after complete remission, high-risk and / or refractory patients ;
  5. Relapse after hematopoietic stem cell transplantation;
  6. For patients with Ph + ALL, the following conditions must be met: those who havereceived a standard induction chemotherapy regimen and who have not achieved completeremission after TKI treatment or have relapsed after remission (cannot tolerate TKItreatment or have contraindications to TKI treatment or the presence of TKI class)Except for drug resistant patients);
  7. Evidence for cell membrane CD19 and CD22 expression;
  8. All genders, ages: 3 to 75 years;
  9. The expect time of survive is above 12 weeks;
  10. KPS>60;
  11. No serious mental disorders ;
  12. Left ventricular ejection fraction ≥50%
  13. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  14. Sufficient renal function defined by creatinine clearance≤2 x ULN;
  15. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  16. With single or venous blood collection standards, and no other cell collectioncontraindications;
  17. Ability and willingness to adhere to the study visit schedule and all protocolrequirements.

Exclusion

Exclusion Criteria:

  1. Have received CAR-T therapy or other genetically modified cell therapy beforescreening;
  2. Participated in other clinical research within 1 month before screening;
  3. Have received the following anti-tumor treatment before screening: Have receivedchemotherapy, targeted therapy or other experimental drug treatment within 4 weeks,except those who have confirmed disease progression after treatment;
  4. Live attenuated vaccine within 4 weeks before screening;
  5. Convulsion or stoke within past 6 months;
  6. Previous history of other malignancy;
  7. Presence of uncontrolled active infection;
  8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer ishigher than the lower limit of detection of the research institution; HCV antibodypositive and peripheral blood HCV RNA titer is higher than the lower limit ofdetection of the research institution; HIV antibody positive; syphilis primaryscreening antibody positive;
  9. Pregnant or breasting-feeding women;
  10. Any situation that investigators regard not suitable for attending in this study ormay affect the data analysis.

Study Design

Total Participants: 40
Study Start date:
August 25, 2020
Estimated Completion Date:
July 01, 2024

Study Description

Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.

Connect with a study center

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

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