Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06081478

CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia

CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 14 years to 85 years, expected survival > 3 months;
  • CD19/CD22 positive B-cell lymphoma or B-ALL;
  • relapsed or refractory to standard first-line treatment;
  • ECOG-PS score=0-2;
  • Having at least one measurable lesions;
  • Cardiac function: 1-2 levels;
  • Liver: TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN;
  • kidney: Cr≤1.25ULN;
  • bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
  • No serious allergic constitution;
  • No other serious diseases that conflicts with the clinical program;
  • No other cancer history;
  • No serious mental disorder;
  • Informed consent is signed by a subject or his lineal relation.

Exclusion criteria

  • Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
  • Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  • Active hepatitis B or hepatitis C infection;
  • Recent or current use of glucocorticoid or other immunosuppressor;
  • With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
  • Participate in other clinical research in the past three months;
  • previously treatment with any gene therapy products;
  • Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.

Treatment and study plan

CD19/CD22-bispecific CAR-T cells

Drug

CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.

Primary outcomes

  1. Best ORR

    Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion

    Overall response rate means sum of complete response rate and partial response rate

Secondary outcomes

  1. Best CR rate

    Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion

    CR was defined as complete remission evaluated using PET-CT scan or BM test

  2. Progression free survival (PFS)

    Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

    PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason

  3. overall survival (OS)

    Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

    OS was defined from the date of CAR-T infusion to the date fo death

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.