Gender
All
Age Group
18 Years to 50 Years
Accepting Healthy Volunteers
No
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-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.
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.