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

NCT06934382 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • T-Cell Acute Lymphoblastic Leukemia/Lymphoma

Interventions

BIOLOGICAL

Allogeneic 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.

Sponsors & Collaborators

  • Beam Therapeutics Inc.

    collaborator INDUSTRY

  • Stephan Grupp MD PhD

    lead OTHER

Principal Investigators

  • Caroline Diorio, MD · Children's Hospital of Philadelphia

  • Stephan Grupp, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
0 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2029-05-30
Completion
2031-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934382 on ClinicalTrials.gov