CD19 and CD22 Targeted CAR-T Cell 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

Chronic Lymphocytic Leukemia

Leukemia

Treatment

N/A

Clinical Study ID

NCT04649983
PBC012
  • Ages 2-75
  • 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 and 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: 2 to 75 years;
  9. The expect time of survive is above 3 months;
  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. Previous history of other malignancy;
  2. Presence of uncontrolled active infection;
  3. Evidence of disorder that need the treatment by glucocorticoids;
  4. Active or chronic GVHD;
  5. The patients treatment by inhibitor of T cell;
  6. Pregnant or breasting-feeding women;
  7. Any situation that investigators regard not suitable for attending in this study (e.g.HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Design

Total Participants: 40
Study Start date:
September 01, 2019
Estimated Completion Date:
July 01, 2024

Study Description

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. 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

  • 920th Hospital of Joint Logistics Support Force

    Kunming, Yunnan
    China

    Active - Recruiting

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