RecruitingPhase 1NCT06408194

Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies

Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Sponsor

Stanford University

Enrollment

20 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Leukemia

Summary

The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.

Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new CAR-T cell therapy targeting a protein called CD22 in patients with B-cell acute lymphoblastic leukemia (a blood cancer) who have relapsed after receiving a different CAR-T therapy (CD19). It aims to overcome resistance when the first CAR-T therapy stops working. **You may be eligible if...** - You have relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (ALL) - You are eligible for commercial tisagenlecleucel (Kymriah) — meaning you have relapsed twice or your cancer did not respond to standard treatment - Your cancer cells show CD19 and CD22 expression **You may NOT be eligible if...** - Your cancer does not express CD22 on its cells - You do not meet the criteria for commercial Kymriah therapy - Your health does not allow safe administration of CAR-T treatment 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

DRUGCD22CART infusion

CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.

DRUGTisagenlecleucel

All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.

Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06408194

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