Clinical trial · Interventional
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
NCT04806035CI-TRIAL-00079310terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic/Business Decision
Summary
Brief summary (as posted)
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Lymphoma | Aggressive Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Indolent Lymphoma | Indolent Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| MCL | Mantle Cell Lymphoma | ALIAS | 0.90 |
| Mediastinal Large B-cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ALIAS | 0.90 |
| Richter's Transformation | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TG-1801 | Biological | — | UNRESOLVED |
| Ublituximab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: TG-1801
- description
- TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.
- interventionNames
- Biological: TG-1801
- type
- EXPERIMENTAL
- label
- Cohort B: TG-1801
- description
- TG-1801 Single Agent, escalating doses
- interventionNames
- Biological: TG-1801
- type
- EXPERIMENTAL
- label
- Cohort C: TG-1801 + Ublituximab
- description
- TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy * Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018) * Treatment Status: 1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics) 2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT 3. CLL subjects: relapsed to or refractory after at least two prior standard therapies * Measurable disease defined as: 1. NHL (including SLL): at least 1 measurable disease lesion \> 1.5 centimeters (cm) 2. CLL: at least 1 measurable disease lesion Exclusion Criteria: * Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy, * Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1. * Prior autologous stem cell transplant (SCT) within 6 months.
References
Publications (1)
- DERIVEDChauchet X, Cons L, Chatel L, Daubeuf B, Didelot G, Moine V, Chollet D, Malinge P, Pontini G, Masternak K, Ferlin W, Buatois V, Shang L. CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. Exp Hematol Oncol. 2022 May 10;11(1):26. doi: 10.1186/s40164-022-00279-w. PMID 35538512