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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoblastic Lymphoma T-Cell Lymphoblastic Leukemia/Lymphoma Lymphoblastic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fludarabine, cyclophosphamide and alemtuzumab

Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab

Group Type EXPERIMENTAL

BEAM-201

Intervention Type BIOLOGICAL

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

Fludarabine, cyclophosphamide without alemtuzumab

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

Group Type EXPERIMENTAL

BEAM-201

Intervention Type BIOLOGICAL

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

Interventions

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BEAM-201

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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-refractory 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-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
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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No