NCT03484702 · OUTCOME
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of Participants
- Interval / dispersion
- Not reported
- Time frame
- At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.
What was measured
Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.
Analysis population: All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results.
Groups in this outcome
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 34 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Reported measurements
Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 34 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 88.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 95.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 80.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 30 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 18 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 4 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 8 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 70.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 66.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 62.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 26 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 16 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 4 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 8 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 61.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 37.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 12 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 11 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 6 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 33.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 45.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 71.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 16.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 12 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 5 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 5 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 4 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 41.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 40.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 60.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 25.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 10 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 7 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 4 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 4 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 40.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 57.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 66.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 8 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 7 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 4 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 2 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 25.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 57.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 75.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 20.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Month 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 7 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 6 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 3 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 2 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 |
|---|
Values in Percent of Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 28.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 20.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 88.2
- group Id
- OG001
- value
- 95.2
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 80.0
- group Id
- OG005
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Day 29
- categories
- measurements
- group Id
- OG000
- value
- 70.0
- group Id
- OG001
- value
- 66.7
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 62.5
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- units
- Participants
- title
- Month 2
- categories
- measurements
- group Id
- OG000
- value
- 61.5
- group Id
- OG001
- value
- 50.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 37.5
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- units
- Participants
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 45.5
- group Id
- OG002
- value
- 71.4
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 16.7
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- value
- 41.7
- group Id
- OG001
- value
- 40.0
- group Id
- OG002
- value
- 60.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 25.0
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- units
- Participants
- title
- Month 9
- categories
- measurements
- group Id
- OG000
- value
- 40.0
- group Id
- OG001
- value
- 57.1
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 66.7
- group Id
- OG005
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- units
- Participants
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- value
- 25.0
- group Id
- OG001
- value
- 57.1
- group Id
- OG002
- value
- 75.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Month 18
- categories
- measurements
- group Id
- OG000
- value
- 28.6
- group Id
- OG001
- value
- 50.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Month 24
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- units
- Participants
- description
- Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.
- groups
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG000
- title
- Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG001
- title
- Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG002
- title
- Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG003
- title
- Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG004
- title
- Cohort 5: Primary Central Nervous System Lymphoma
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG005
- title
- Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
- param Type
- NUMBER
- population Description
- All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results.
- reporting Status
- POSTED
- time Frame
- At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.
- title
- Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
- type
- SECONDARY
- unit Of Measure
- Percent of Participants
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Preserved source evidence · Not medical advice
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