TriangleNCT03277729 · STUDY IN CONTEXT
A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relap
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
Will be assessed based on the Lugano criteria.
A Cox proportional hazards model will be used to evaluate PFS.
A Cox proportional hazards model will be used to evaluate OS.
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- trial label
- A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relap
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- source section id
- NCT03277729-om-0000
- source outcome index
- 0
- endpoint
- Dose-limiting Toxicities (DLT) Rate
- endpoint definition
- Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
- time origin
- Up to 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0001
- source section id
- NCT03277729-om-0001
- source outcome index
- 1
- endpoint
- Complete Remission
- endpoint definition
- Will be assessed based on the Lugano criteria.
- time origin
- Up to 15 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0002
- source section id
- NCT03277729-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- A Cox proportional hazards model will be used to evaluate PFS.
- time origin
- Duration from study enrollment to progression or death due to any cause (whichever comes first), assessed up to 15 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0003
- source section id
- NCT03277729-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- A Cox proportional hazards model will be used to evaluate OS.
- time origin
- Duration from study enrollment to death due to any cause, assessed up to 15 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0004
- source section id
- NCT03277729-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Adverse Events
- endpoint definition
- Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
- time origin
- Up to 15 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 0 of CD20 CAR T Cells
- regimen
- Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03277729-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 1 of CD20 CAR T Cells
- regimen
- Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03277729-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Dose Level 2 of CD20 CAR T Cells
- regimen
- Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03277729-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Dose Level 3 of CD20 CAR-T Cells
- regimen
- Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03277729-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Dose Level 4 of CD20 CAR-T Cells
- regimen
- Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03277729-om-0000#groups/OG004
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- harm key
- EG000
- source section id
- NCT03277729-ae
- event group key
- EG000
- event group label
- Dose Level 0 of CD20 CAR T Cells
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- harm key
- EG001
- source section id
- NCT03277729-ae
- event group key
- EG001
- event group label
- Dose Level 1 of CD20 CAR T Cells
- serious affected
- 2
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 0
- collection period
- Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- harm key
- EG002
- source section id
- NCT03277729-ae
- event group key
- EG002
- event group label
- Dose Level 2 of CD20 CAR T Cells
- serious affected
- 1
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- harm key
- EG003
- source section id
- NCT03277729-ae
- event group key
- EG003
- event group label
- Dose Level 3 of CD20 CAR-T Cells
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors-recurrent-31ec95fa
- nct id
- NCT03277729
- harm key
- EG004
- source section id
- NCT03277729-ae
- event group key
- EG004
- event group label
- Dose Level 4 of CD20 CAR-T Cells
- serious affected
- 18
- serious at risk
- 31
- other affected
- 31
- other at risk
- 31
- frequency threshold
- 0
- collection period
- Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice