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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Beam Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
1,121 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am approved for a stem cell transplant and have a donor.I have previously received CD7 targeted therapy.My T-ALL/T-LL cancer is in its second or later relapse, has come back after a transplant, or hasn't responded to chemotherapy.I have received treatment for leukemia within the last 14 days.I have brain-related symptoms or permanent nerve damage from past leukemia treatments.I am between 1 and 17 years old.My cancer has spread to my brain or spinal cord.I am between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Fludarabine, cyclophosphamide and alemtuzumab
- Group 2: Fludarabine, cyclophosphamide without alemtuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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