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Also known as Allogeneic anti-CD7 CAR-T cells (BEAM-201), Allogeneic anti-CD7 CAR-T cells
BEAM-201 · 2 trials · 4 indications
The Maximum Tolerated Dose will be determined by measuring the incidence of dose limiting toxicities following administration of the product.
Frequency of Adverse events will be measured by evaluating the frequency and severity of treatment related adverse events following administration of Beam-201 Cells
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm | EXPERIMENTAL | 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. Should there be sufficient clinical response at lower doses (i.e. DL1 or DL2), then the sponsor and principal investigator may choose to forgo further dose escalation and proceed to dose expansion at the lower dose level. |
| Dose Expansion Arm | EXPERIMENTAL | 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. |
| 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 |
|---|---|---|
| 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. |
| BEAM-201 | BIOLOGICAL | A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens |
Patients must meet all the following criteria to be eligible for enrollment into the study: 1. Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements. 2. Ages 0 to 29 ye...
BEAM-201 is an investigational allogeneic anti-CD7 CAR-T cell therapy being developed by Beam Therapeutics Inc. for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. It is a cell-based oncology therapy designed to treat patients whose disease has returned or has not responded to prior treatment.
BEAM-201 is being studied for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, including lymphoblastic lymphoma. Both conditions are aggressive blood cancers. The program is in Phase 1 clinical development, so the therapy has not been approved for commercial use in any indication.
BEAM-201 targets CD7, a protein expressed on T-cell leukemia and lymphoma cells. It is an allogeneic anti-CD7 CAR-T cell therapy, meaning the CAR-T cells are derived from donor cells rather than from the patient, and they are engineered to recognize and act against CD7-positive cancer cells.
BEAM-201 is being developed by Beam Therapeutics Inc., which trades on the Nasdaq under the ticker BEAM. The company is the sponsor of the clinical program evaluating the therapy in T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
BEAM-201 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program consists of early-stage studies evaluating the therapy in patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoma.
BEAM-201 is being evaluated in two Phase 1 studies. NCT05885464 is an active, not recruiting study of BEAM-201 in relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma with an enrollment of 5. NCT06934382 is a recruiting Phase 1 study in relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoma with an enrollment of 33.
Yes. BEAM-201 is also known as allogeneic anti-CD7 CAR-T cells (BEAM-201), or simply allogeneic anti-CD7 CAR-T cells. These names refer to the same investigational Beam Therapeutics product candidate being studied in T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.