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A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

Recruiting
2-80 years
All
Phase 1

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Overview

Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.

Eligibility

Inclusion Criteria:

CD19 positive leukemia and lymphoma,relapsed and/or refractory:

  • survival>12 weeks;
  • FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
  • LVEF≥50%;
  • Creatinine<2.5mg/dl;
  • Bilirubin<2.5mg/dl;
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
  • At least 7 days after last chemotherapy;
  • provide with informed consent.

Exclusion Criteria:

  • Active clinically significant CNS dysfunction
  • Pregnant or breast-feeding women.
  • Uncontrolled active infection including hepatitis B or C.
  • HIV positive.
  • Use of systemic steroids within 72 hours.
  • Allogeneic lymphocyte treatments within recent 6 months.
  • Any uncontrolled active medical disorder.

Study details
    B Cell Leukemia
    B Cell Lymphoma

NCT03383952

Immune Cell, Inc.

28 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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