Clinical trial · Interventional
FT819 in Subjects With B-cell Malignancies
A Phase I Study of FT819 in Subjects With B-cell Malignancies
NCT04629729CI-TRIAL-00106025active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Precursor B-Cell Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| FT819 | Drug | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- FT819 Single-Dose Monotherapy, B-Cell Lymphoma
- description
- FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
- interventionNames
- Drug: FT819
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Bendamustine
- type
- EXPERIMENTAL
- label
- FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
- description
- FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
- interventionNames
- Drug: FT819
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: IL-2
- Drug: Bendamustine
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: Diagnosis of B-cell lymphoma, CLL or B-ALL as described below: B-Cell Lymphoma: * Histologically documented lymphomas expected to express CD19 * Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy Chronic Lymphocytic Leukemia (CLL): * Diagnosis of CLL per iwCLL guidelines * Relapsed/refractory disease following at least two prior systemic treatment regimens Precursor B-cell Acute Lymphocytic Leukemia (B-ALL): * Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics * Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen ALL SUBJECTS: * Capable of giving signed informed consent * Age ≥ 18 years old * Stated willingness to comply with study procedures and duration * Contraceptive use for women and men as defined in the protocol Key Exclusion Criteria: ALL SUBJECTS: * Females who are pregnant or breastfeeding * Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 * Body weight \<50 kg * Evidence of insufficient organ function * Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1 * Currently receiving or likely to require systemic immunosuppressive therapy * Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T * Receipt of an allograft organ transplant * Known active central nervous system (CNS) involvement by malignancy * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Clinically significant cardiovascular disease * Positive serologic test results for HIV infection * Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection * Positive serologic and PCR test results for Hepatitis C (HCV) infection * Live vaccine \<6 weeks prior to start of lympho-conditioning * Known allergy to albumin (human) or DMSO
References
Publications (0)
Data not yet available
No reference posted for this study.