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CAR T-cell Therapy

BEAM-201 for T-cell Leukemia/Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Beam Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 25 months
Awards & highlights

Study Summary

This trial is testing a new treatment for kids with an aggressive form of leukemia. It will study its safety and effectiveness.

Who is the study for?
This trial is for people aged 1 to 50 with T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma that has come back or didn't respond to treatment. They should have a certain amount of cancer cells in their bone marrow or evidence of the disease after a second remission, and be eligible for a type of stem cell transplant.Check my eligibility
What is being tested?
The study tests BEAM-201's safety and effectiveness on patients with relapsed/refractory T-ALL/T-LL. It includes initial dose-finding, expansion cohorts, a pediatric group (ages 1 to <12), and Phase 2 cohort to determine how well it works at selected doses.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones may include reactions at the infusion site, general discomforts like fatigue or fever, potential organ inflammation due to immune response, and increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events, including serious adverse events (SAEs) and dose-limiting toxicities (DLTs; in Phase 1 only)
Overall response rate as defined as proportion of T-ALL patients achieving complete response (CR) or complete response with incomplete hematologic recovery (CRi) or T-LL patients achieving CR or PR at any point after BEAM-201 infusion
Secondary outcome measures
Duration of Response (DOR)
Overall survival
Proportion of patients treated with BEAM-201 deemed appropriate for HSCT based on investigator assessment of clinical response
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Fludarabine, cyclophosphamide without alemtuzumabExperimental Treatment1 Intervention
Lymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm
Group II: Fludarabine, cyclophosphamide and alemtuzumabExperimental Treatment1 Intervention
Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab

Find a Location

Who is running the clinical trial?

Beam Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
1,121 Total Patients Enrolled

Media Library

BEAM-201 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05885464 — Phase 1 & 2
Lymphoblastic Leukemia Research Study Groups: Fludarabine, cyclophosphamide and alemtuzumab, Fludarabine, cyclophosphamide without alemtuzumab
Lymphoblastic Leukemia Clinical Trial 2023: BEAM-201 Highlights & Side Effects. Trial Name: NCT05885464 — Phase 1 & 2
BEAM-201 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05885464 — Phase 1 & 2
~68 spots leftby Dec 2031
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