Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BEAM-201 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Fludarabine, cyclophosphamide and alemtuzumab | EXPERIMENTAL | Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab |
| Fludarabine, cyclophosphamide without alemtuzumab | EXPERIMENTAL | Lymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm |
| Name | Type | Description |
|---|---|---|
| BEAM-201 | BIOLOGICAL | A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens |
Key Inclusion Criteria: 1. Ages 18 to ≤ 50 years. 2. Ages ≥ 1 year to \< 18 years, after health authority approval. 3. T-ALL/T-LL that is CD7-positive (defined as at least 20% of blasts positive for CD7 by flow cytometry or immunohistochemistry based on assessment of the study site's CLIA \[Clinica...
BEAM-201 is an investigational monoclonal antibody being developed for the treatment of lymphoblastic lymphoma, specifically relapsed or refractory T-cell lymphoblastic lymphoma (T-LL). It is also being studied in T-cell acute lymphoblastic leukemia (T-ALL). The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
BEAM-201 is being developed by Beam Therapeutics Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BEAM. The company is conducting clinical research on this investigational therapy for oncology indications.
BEAM-201 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is evaluating the safety and efficacy of the drug in patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
BEAM-201 is being studied in one active Phase 1 clinical trial with the identifier NCT05885464. This trial is evaluating the safety and efficacy of BEAM-201 in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL). The study is enrolling adults aged 18 years and older in the United States.
BEAM-201 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is evaluating its safety and efficacy, and the drug has not yet completed the clinical development process required for regulatory approval.