RecruitingPhase 1NCT07361029

CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia

Phase Ia Study of a LentiGen® CD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL) Using a Closed Transduction System


Sponsor

King Faisal Specialist Hospital & Research Center

Enrollment

24 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy that targets the CD19 protein for adults with acute lymphoblastic leukemia (ALL), a blood cancer, that has come back or is no longer responding to chemotherapy. **You may be eligible if...** - You are 18–75 years old - You have B-cell ALL that has relapsed at least twice, or did not respond to two rounds of standard chemotherapy - Your leukemia is Philadelphia chromosome-positive and you have failed or cannot tolerate two tyrosine kinase inhibitor drugs - You have relapsed after a stem cell transplant - You cannot have or don't have a suitable donor for a stem cell transplant - At least 5% of your bone marrow contains leukemia cells - Your cancer cells still express CD19 **You may NOT be eligible if...** - Your leukemia no longer expresses CD19 - You have had severe reactions (grade 3 or higher) to previous CAR-T therapy - You have active brain or spinal cord involvement by leukemia (unless you are in remission for that) - You are pregnant or breastfeeding - Your organ function is inadequate for the therapy 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

OTHERCAR T cells chimeric antigen receptor cells

CAR T Cells


Locations(1)

King Faisal Specialist Hospital and Research Center

Riyadh, Riyadh Region, Saudi Arabia

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NCT07361029