Active — Not RecruitingPhase 1/2

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)

United States5 participantsStarted 2023-05-25

Plain-language summary

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a Phase 2 cohort.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Ages 18 to ≤ 50 years.
✓. Ages ≥ 1 year to \< 18 years, after health authority approval.
✓. 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 \[Clinical Laboratory Improvement Amendments of 1988\] certified facility) in second or greater relapse, first relapse post-transplant relapse, or chemotherapy-refractory disease. Specifically:
✓. Second or greater relapse or post-transplant relapse, defined as:
✓. Refractory disease, defined as:
✓. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.

Exclusion criteria

✕. CNS involvement meeting any of the following criteria: CNS-3 disease, progressive CNS involvement despite therapy, CNS parenchymal or cranial nerve lesions on imaging.
✕. Clinically active CNS dysfunction or known history of irreversible neurological toxicity related to prior antileukemic therapy.
✕. Receipt of prior CD7 targeted therapy.
✕. Systemic antileukemic therapy intended to induce or maintain remission within 14 days prior to completion of screening.

What they're measuring

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)

Timeframe: Through study completion, an average of 25 months

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

Timeframe: From treatment with BEAM-201 through study completion

Trial details

NCT IDNCT05885464

SponsorBeam Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

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