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

Conditions

• T-Cell Acute Lymphoblastic Leukemia/Lymphoma

Eligibility Criteria

Sex

ALL

Age

0 Years - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic anti-CD7 CAR-T cells (BEAM-201) — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Apr 29, 2025

Status verified

Dec 2025

Primary completion

May 30, 2029

Completion

May 30, 2031

Study Design

Enrollment

33 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Arm
  The dose escalation portion of the trial will use a standard "3+3" design to establish the recommended maximum tolerated dose of BEAM-201 cells. Three dose escalations of BEAM-201 are planned for the dose escalation phase, with one dose de-escalation level if needed.
• Experimental: Dose Expansion Arm
  If at least one dose level of the dose escalation phase is determined to be safe, the dose expansion phase of the trial will be opened to enrollment.

Primary Outcome Measure

Determine the Maximum Tolerate Dose of Beam 201 Cells [ Time Frame: 5 years ]

Central Contacts

• Cell Therapy Intake Team
  445-942-5891
  [email protected]
• Melissa S Varghese, M.S.
  845-553-5358
  [email protected]

Locations (1)

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