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Active, not recruitingNCT05885464Updated Jan 13, 2025

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)

A Phase 1/2 interventional study of BEAM-201 in Lymphoblastic Lymphoma, T-Cell Lymphoblastic Leukemia/Lymphoma and Lymphoblastic Leukemia, sponsored by Beam Therapeutics Inc.. Active, not recruiting at 10 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Beam Therapeutics Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphoblastic Lymphoma
  • T-Cell Lymphoblastic Leukemia/Lymphoma
  • Lymphoblastic Leukemia

Keywords

  • Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Base editing
  • CAR-T
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Beam Therapeutics Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 [Clinical Laboratory Improvement Amendments of 1988] certified facility) in second or greater relapse, first relapse post-transplant relapse, or chemotherapy- disease. Specifically:

    1. Second or greater relapse or post-transplant relapse, defined as:

      • BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening after second documented CR; OR
      • Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR
      • Any detectable relapsed disease post- HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR
      • confirmed evidence of relapsed T-LL on lymph node biopsy after second CR; OR
      • Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LL on lymph node biopsy

    2. Refractory disease, defined as:

      • Primary refractory T-ALL or T-LL, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-confirmed evidence of residual T-ALL or T-LL; OR
      • Relapsed, refractory disease, defined as > 5% BM blasts or biopsy-confirmed evidence of residual TLL after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T-cell dominant phenotype may be enrolled if the aforementioned criteria are met.
  4. 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.

Key Exclusion Criteria:

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Fludarabine, cyclophosphamide and alemtuzumab

    Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab

    Biological: BEAM-201

  • Experimental
    Fludarabine, cyclophosphamide without alemtuzumab

    Lymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm

    Biological: BEAM-201

Interventions

  • BiologicalBEAM-201

    A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Through study completion, an average of 25 months

  2. 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

    Time frame: From treatment with BEAM-201 through study completion

Secondary outcomes

  1. Proportion of patients who achieve MRD negative response (defined as < 0.1%) by flow cytometry or next generation sequencing (NGS) in patients achieving morphologic response

    Time frame: Starting at Day 28 and multiple time points up to Month 24

  2. Proportion of patients treated with BEAM-201 deemed appropriate for HSCT based on investigator assessment of clinical response

    Time frame: Through study completion, an average of 25 months

  3. Duration of Response (DOR)

    Time frame: Through study completion, an average of 25 months

  4. Relapse-free survival (RFS)

    Time frame: Through study completion, an average of 25 months

  5. Overall survival

    Time frame: Through study completion, an average of 25 months

  6. Relapse-related mortality

    Time frame: Through study completion, an average of 25 months

07

Study locations

10 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.

Of 114 phase 1/2 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 56 and three quarters within 119. This study's planned 43 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2023
First posted
Jun 2, 2023
StartActual
May 25, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jan 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05885464
Lead sponsor
Beam Therapeutics Inc.
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
May 25, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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