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Recruiting NCT04781634

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

Phase I / Phase II Interventional B-ALL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD19 and CD22 targeted prime CAR-T cells.
Who it may be relevant to
Registry conditions: B-ALL. Basic parameters: 2 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

Overview

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 -ALL

Detailed 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-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Interventions

  • Biological CD19 and CD22 targeted prime CAR-T cells
    A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

Primary outcome measures

  • Adverse events that related to treatment [Time frame: 2 years]
  • The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL [Time frame: 6 months]
Secondary outcome measures (12)
  • Rate of prime CAR-T cells in bone marrow [Time frame: 2 years]
  • Rate of prime CAR-T cells in peripheral blood [Time frame: 2 years]
  • Quantity of prime CAR copies in bone marrow [Time frame: 2 years]
  • Quantity of prime CAR copies in peripheral blood [Time frame: 2 years]
  • Rate of CD19 and CD22 positive cells in Bone marrow [Time frame: 1 years]
  • Levels of IL-6 in Serum [Time frame: 3 months]
  • Levels of IL-10 in Serum [Time frame: 3 months]
  • Levels of TNF-α in Serum [Time frame: 3 months]
  • Levels of CRP in Serum [Time frame: 3 months]
  • Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL [Time frame: 2 years]
  • Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL [Time frame: 2 years]
  • Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD
  • The patients treatment by inhibitor of T cell
  • Pregnant or breasting-feeding women;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 920th Hospital of Joint Logistics Support Force — Kunming

Identifiers

NCT: NCT04781634 · PBC025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗