RecruitingPhase 1Phase 2NCT05442515

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Phase 1/2 Dose Escalation Study of CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies


Sponsor

National Cancer Institute (NCI)

Enrollment

126 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....


Eligibility

Min Age: 3 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called CAR-T cells — immune cells that are specially engineered to attack two proteins (CD19 and CD22) found on cancer cells — in children and young adults whose B-cell leukemia or lymphoma has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with B-cell ALL, CML with ALL transformation, or certain B-cell lymphomas - Your cancer has relapsed or not responded to at least one standard and one salvage (rescue) treatment - You are not eligible for a stem cell transplant, have refused it, or have relapsed after one - You have no active graft-versus-host disease (from a prior transplant) **You may NOT be eligible if...** - You have active, uncontrolled infection - Your cancer is only in the brain or testes - Your organ function is too poor to tolerate the treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19/CD22-CAR-transduced T cells

CD19/CD22-CAR-transduced T cells on D0 after lymphodepleting preparative regimen

DRUGcyclophosphamide

Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion.

DRUGfludarabine

Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05442515


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