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CAR T-cell Therapy

BEAM-201 for T-cell Leukemia/Lymphoma

Q: Are geriatric individuals being considered for inclusion in this clinical trial?

Patients aged 18 to 50 years old are eligible for this research study.

Q: What qualifications do participants need to satisfy in order to join this research?

This trial seeks 102 participants with lymphoblastic <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, aged 18-50.

Q: Are any new participants currently being sought out for this research?

According to information available on the website of clinicaltrials.gov, this particular medical study is not actively recruiting patients at present. The trial was first listed in May 25th 2023 and has been amended most recently on June 1st 2023. Although no candidates are being sought after right now, there remain 2888 other studies that presently require participants' involvement.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 25 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Beam Therapeutics Inc.Lead Sponsor

2 Previous Clinical Trials

1,015 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being considered for inclusion in this clinical trial?

"Patients aged 18 to 50 years old are eligible for this research study."

Answered by AI

What qualifications do participants need to satisfy in order to join this research?

"This trial seeks 102 participants with lymphoblastic lymphoma, aged 18-50."

Answered by AI

Are any new participants currently being sought out for this research?

"According to information available on the website of clinicaltrials.gov, this particular medical study is not actively recruiting patients at present. The trial was first listed in May 25th 2023 and has been amended most recently on June 1st 2023. Although no candidates are being sought after right now, there remain 2888 other studies that presently require participants' involvement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)

2023. "A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05885464.

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