a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

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

Phase

1/2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT04782193
PBC026
  • Ages 2-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent
  2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following 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. Evidence for cell membrane CD19 or CD22 expression
  7. All genders ages: 2 to 75 years
  8. The expect time of survive is above 3 months;
  9. KPS>60
  10. No serious mental disorders ;
  11. Left ventricular ejection fraction ≥50%
  12. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  13. Sufficient renal function defined by creatinine clearance≤2 x ULN;
  14. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  15. With single or venous blood collection standards, and no other cell collectioncontraindications;
  16. 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:
May 23, 2021
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, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Connect with a study center

  • 920th Hospital of Joint Logistics Support Force

    Kunming, Yunnnan
    China

    Active - Recruiting

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