Clinical trial · Observational
Long-term Study to Evaluate Safety and Persistence of GF-CART01
A Long-term Follow-up Study of GF-01-01 to Evaluate the Safety and Persistence of GF-CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies
NCT06985576CI-TRIAL-00114451enrolling by invitationClinicalTrials.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)
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | PROBABILISTIC | 0.70 |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| High Grade B Cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Primary Mediastinal Large B-Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- LTFU
- description
- Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are invited to participate in this follow-up study.
Primary outcomes (1)
- measure
- Long-Term Safety of GF-CART01 after infusion
- timeFrame
- up to 15 years after GF-CART01 infusion
- description
- Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)
Secondary outcomes (2)
- measure
- GF-CART01 persistence
- timeFrame
- up to 15 years after GF-CART01 infusion
- description
- Measure the duration of GF-CART01 presence after cell infusion * Clast * Time of Clast
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion 2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent 3. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement Exclusion Criteria: None
References
Publications (0)
Data not yet available
No reference posted for this study.