RecruitingPhase 1NCT06934382

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

A Phase 1 Study of Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-cell Lymphoblastic Lymphoma (T-LLy)


Sponsor

Stephan Grupp MD PhD

Enrollment

33 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.


Eligibility

Min Age: 0 YearsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a cutting-edge treatment called anti-CD7 CAR-T cell therapy for patients with relapsed or treatment-resistant T-cell acute lymphoblastic leukemia (T-ALL) — a fast-growing blood cancer. CAR-T therapy involves re-engineering a patient's own immune cells to seek and destroy cancer cells. **You may be eligible if...** - You have been diagnosed with T-cell acute lymphoblastic leukemia (T-ALL) - Your leukemia has come back after treatment or has not responded to at least one prior treatment - You are an adult (or meet the age criteria for the study) - Your cancer cells test positive for the CD7 protein **You may NOT be eligible if...** - You have uncontrolled infections, including active HIV or hepatitis - You have serious heart, lung, liver, or kidney problems - You have had prior CAR-T therapy with insufficient recovery time - You are pregnant or breastfeeding - Your cancer has spread to the brain and is not controlled 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

BIOLOGICALAllogeneic anti-CD7 CAR-T cells (BEAM-201)

The investigational agent in this protocol is allogeneic anti-CD7 CART cells (BEAM-201). BEAM-201 is comprised of allogeneic anti-CD7 CAR-T cells edited by 4 gRNAs and a single mRNA encoding a CBE, then transduced with a lentiviral vector (LVV) encoding the anti-CD7 chimeric antigen receptor (CAR) molecule.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT06934382