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Lymphoblastic LymphomaPhase 1/2NCT05885464

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 study testing BEAM-201 in people with Lymphoblastic Lymphoma and T-Cell Lymphoblastic Leukemia/Lymphoma, run by Beam Therapeutics Inc. at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
BEAM-201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
10 sitesUnited States
Study dates
25 May 2023to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • 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
Show all 13Show fewer
  • Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR
  • Biopsy 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
  • 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.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Dana Farber and Boston Children's Hospital

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic- Taussig Cancer Center

    Cleveland, Ohio, 44106

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • The University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • Sarah Cannon- TriStar Bone Marrow Transplant

    Nashville, Tennessee, 37203

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland, Oregon, 97239

  • Methodist Hospital - Texas Transplant Institute

    San Antonio, Texas, 78229

  • Stanford University School of Medicine

    Stanford, California, 94304

Other trials in United States

About this study

Official title: A Phase 1/2, Dose-Exploration and Dose-Expansion Study Evaluating the Safety and Efficacy of Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)

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.

Being tested
BEAM-201
Keywords
Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Base editing, CAR-T
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEAM-201Biological

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

Study groups in NCT05885464
Study groupRoleWhat they receive
Fludarabine, cyclophosphamide and alemtuzumabExperimentalLymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab
Receives: Biological: BEAM-201
Fludarabine, cyclophosphamide without alemtuzumabExperimentalLymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm
Receives: Biological: BEAM-201

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: From treatment with BEAM-201 through study completion

Secondary outcomes (6)

  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

    Measured: 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

    Measured: Through study completion, an average of 25 months

  3. Duration of Response (DOR)

    Measured: Through study completion, an average of 25 months

  4. Relapse-free survival (RFS)

    Measured: Through study completion, an average of 25 months

  5. Overall survival

    Measured: Through study completion, an average of 25 months

  6. Relapse-related mortality

    Measured: Through study completion, an average of 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start25 May 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The maximum number of patients for this study is approximately 102 patients: * 36 patients in the Phase 1 dose exploration * approximately 12 patients in the Phase 1 dose-expansion cohorts * 6 patients in the pediatric cohort * approximately 48 patients in the Phase 2 cohort.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885464
Sponsor's protocol ID
BTX-ALO-001
Status last verified
Jan 2025
First submitted
23 May 2023
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BEAM-201 in people with Lymphoblastic Lymphoma and T-Cell Lymphoblastic Leukemia/Lymphoma, run by Beam Therapeutics Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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