Trial · NCT03049449
T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas
NCT03049449, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2022-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas. Trials, record NCT03049449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03049449
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas
- NCT number
- NCT03049449
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, Large-Cell, Anaplastic, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Extranodal NK-T-Cell, Lymphoma, T-Cell, Peripheral
- Interventions
- Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) T cells, Cyclophosphamide, Fludarabine
- First posted
- 2017-02-10
- Last updated
- 2023-01-18
- Results first posted
- 2022-05-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) in Participants With Advanced CD30-expressing Lymphomas | 4-5 weeks after first dose | Maximum tolerated dose is defined as the dose at which a maximum of 1 of 6 participants has a dose-limiting toxicity (DLT). A DLT is defined as toxicities occurring within 30 days of CAR T-cell infusion. DLT's are Grade 3 or Grade 4 toxicities possibly, probably, or definitely related to either the anti-CD30 CAR T cells or the fludarabine and cyclophosphamide chemotherapy conditioning regimen and lasting more than 7 days. A DLT will only be considered in participants who have received CAR T-cell infusions. |
| Secondary | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | From time of infusion until 1 month after infusion | Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). |
| Secondary | Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression as Their Best Response | Responses will be assessed as long as the patient is on-study at the following time-points: 1, 2, 3, 4, 6, 9, and 12 months after CAR T-cell infusion. Then responses were assessed every 6 months up until 3 years after CAR T-cell infusion. | Response was measured using the Cheson et al. Revised Response Criteria for Malignant Lymphoma, Journal of Clinical Oncology 2007 and Recommendations for Initial Evaluation, Staging, and Response Assessment of Non-Hodgkin Lymphoma: The Lugano Classification Journal of Clinical Oncology, 2014). Complete Response (CR) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response (PR) is ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive Disease (PD) ≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With a Dose Limiting Toxicity (DLT) | 30 days within CAR T-cell infusion | A DLT is defined as toxicities occurring within 30 days of CAR T-cell infusion. DLT's are Grade 3 or Grade 4 toxicities possibly, probably, or definitely related to either the anti-CD30 CAR T cells or the fludarabine and cyclophosphamide chemotherapy conditioning regimen and lasting more than 7 days. A DLT will only be considered in participants who have received CAR T-cell infusions. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) in Participants With Advanced CD30-expressing Lymphomas | 4-5 weeks after first dose | million CAR T-cells/kg | NUMBER | |
| SECONDARY | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | From time of infusion until 1 month after infusion | Participants #8, and 23 were not assigned to a dose level since they didn't receive chemo or cells. Participant # 5 first enrolled as #3 did not result in cell infusion and was re-enrolled with a new number for cell infusion. This is the same for #18 who was first enrolled as #16. | peak percentage | NUMBER |
| SECONDARY | Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression as Their Best Response | Responses will be assessed as long as the patient is on-study at the following time-points: 1, 2, 3, 4, 6, 9, and 12 months after CAR T-cell infusion. Then responses were assessed every 6 months up until 3 years after CAR T-cell infusion. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose Limiting Toxicity (DLT) | 30 days within CAR T-cell infusion | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) in Participants With Advanced CD30-expressing Lymphomas | All Participants | 3 | million CAR T-cells/kg | ||
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #1 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 2.505994998 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #2 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 1.003513397 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #4 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 0.257878064 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #5 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 5.692026394 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #6 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 0.066168665 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #7 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 0.875579553 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #9 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 10.425784436 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant 10 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 1.173870125 | peak percentage | |
| Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | Participant #11 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | 25.06555951 | peak percentage |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level -1 - 0.15x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | |
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 | |
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 4 | |
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 8 | |
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 5 | |
| Overall Study | STARTED | Dose Escalation Cohort 1 Dose Level 5 - 18x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | |
| Overall Study | STARTED | Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 | |
| Overall Study | STARTED | Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 1 | |
| Overall Study | STARTED | Cohort 1 No Level Assigned - Enrolled But Not Treated | 1 | |
| Overall Study | STARTED | Cohort 2 No Level Assigned - Enrolled But Not Treated | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 1 | 7 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 1 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 7 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 1 | 5 | 1 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 7 |
| Total, all-cause mortality | Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 5 |
| Total, all-cause mortality | Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 1 |
| Total, other adverse events | Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 | 3 |
| Total, other adverse events | Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 | 3 |
| Total, other adverse events | Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 7 | 7 |
| Total, other adverse events | Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 5 | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37939262 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03049449
GET https://conductscience.org/api/trials/v1/NCT03049449/results?page=2