Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study has 2 parts.
The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or
refractory B-cell Non-Hodgkin Lymphoma.
The main aim of Part 2 is to learn if lymphomas are reduced or gone after treatment
withTAK-007 in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma or indolent
non-Hodgkin lymphoma (iNHL).
Participants will receive lymphodepleting chemotherapy for 3 days before receiving a single
injection of TAK-007. After this, participants will regularly visit the clinic for check-ups.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
1. Participants who have a life expectancy ≥12 weeks.
2. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1
3. Participants with a diagnosis of previously treated r/r histologically proven Cluster
of Differentiation (CD)19 expressing disease of the following types:
a. LBCL, including the following subtypes defined by the World Health Organization
(WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii.
High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii.
HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular
lymphoma (FL) or marginal zone lymphoma (MZL).
v. T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii.
Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix.
Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including
the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal,
extranodal, and splenic).
4. Participants who have measurable disease, defined as at least 1 lesion per the Lugano
classification. Lesions situated in a previously irradiated area are considered
measurable if radiographic progression has been documented in such lesions following
completion of radiation therapy. LBCL should have positron emission tomography
-positive disease per the Lugano classification.
5. Participants whose disease is r/r after at least 2 prior lines of systemic therapy:
1. Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody
(mAb) and an anthracycline containing chemotherapy regimen and failed or be
ineligible for high-dose chemotherapy and autologous stem cell transplantation
(ASCT).
2. Participants with iNHL must have received an anti-CD20 mAb and an alkylating
agent (eg, bendamustine or cyclophosphamide).
3. Preinduction salvage chemotherapy and ASCT should be considered 1 therapy.
4. Any consolidation/maintenance therapy after a chemotherapy regimen (without
intervening relapse) should be considered 1 line of therapy with the preceding
combination therapy. Maintenance antibody therapy should not be considered a line
of therapy.
5. Single-agent anti-CD20 mAb therapy should not be considered a line of therapy.
6. Participants who have adequate bone marrow function defined as follows:
1. Absolute neutrophil count >500/μL.
2. Platelet count of >50,000/μL at screening. Participants with
transfusion-dependent thrombocytopenia are excluded.
7. Participants who have adequate renal, hepatic, cardiac, and pulmonary function as
defined in the study protocol:
1. Estimated glomerular filtration rate (GFR; Modification of Diet in Renal Disease
equation [MDRD]) ≥30 mL/min.
2. Serum alanine aminotransferase/aspartate aminotransferase ≤5 times the upper
limit of normal range (ULN), as long as participant is asymptomatic.
3. Total bilirubin ≤2 mg/dL. Participants with Gilbert's syndrome may have a
bilirubin level >2 × ULN, per discussion between the investigator and the medical
monitor.
4. Left ventricular ejection fraction (LVEF) ≥40% as determined by an echocardiogram
(ECHO) or multigated acquisition (MUGA) scan performed within 1 month of
determination of eligibility.
5. No evidence of clinically relevant pericardial effusion, and no acute clinically
significant electrocardiogram (ECG) findings.
6. Absence of Grade ≥2 pleural effusion. Grade 1 stable pleural effusions are
allowed.
7. Baseline oxygen saturation >92% on room air.
8. Participants are required to consent to provide either sufficient archived
formalin-fixed paraffin embedded (at least 10 unstained slides, ideally 20 unstained
slides) or fresh tumor tissue obtained after the last relapse (see laboratory manual
for details). Exception may be granted by sponsor medical monitor per discussion with
investigator.
Exclusion Criteria:
1. Participants with total body weight of <40 kg.
2. Participants with primary or secondary central nervous system (CNS) involvement by
lymphoma. Participants with a history of secondary CNS involvement by lymphoma without
evidence of CNS involvement at screening may be included.
3. Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma,
or transformation from CLL/small lymphocytic lymphoma (Richter transformation).
4. Participants with a history of malignancy other than nonmelanoma skin cancer,
carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured
and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed
gastric cancer) or unless disease free for ≥3 years at screening.
5. Participants who have undergone autologous or allogeneic transplant or Chimeric
antigen receptor T cells (CAR-T) therapy within 3 months of planned enrollment.
Participants after allogeneic transplant have to be off systemic immunosuppressive
therapy and without the evidence of clinically relevant acute or chronic
graft-versus-host disease (GvHD) at the time of enrollment.
6. Treatment with any investigational products or any systemic anticancer treatment
within 14 days or 2 half-lives of the treatment (whichever is longer) before
conditioning therapy.
7. Participants with active infection, including fungal, bacterial, viral, or other
infection that is uncontrolled or requires IV antimicrobials for management within 3
days before enrollment.
8. Participants with a history or presence of active or clinically relevant CNS disorder,
such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, severe dementia,
cerebellar disease, or any autoimmune disease with CNS involvement. For CNS disorders
that recover or are in remission, participants without recurrence within 2 years of
planned study enrollment may be included.
9. Participants with any of the following within 6 months of enrollment: myocardial
infarction, cardiac angioplasty or stenting, unstable angina, symptomatic congestive
heart failure (ie, New York Heart Association Class II or greater), clinically
significant arrythmia (including uncontrolled atrial fibrillation), or any other
clinically significant cardiac disease.
10. Participants who have received a live vaccine ≤6 weeks before the start of the
conditioning regimen.