Trial Outcomes & Findings for A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies (NCT NCT05588440)
NCT ID: NCT05588440
Last Updated: 2024-12-05
Results Overview
This is based on subject treated with ONCT-808. ONCT-808 1x10\^6 CAR T cells/kg: n=3 ONCT-808 3x10\^6 CAR T cells/kg: n=1 ONCT-808 0.3x10\^6 CAR T cells/kg: n=2
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 28 days after the one-time infusion of ONCT-808
Results posted on
2024-12-05
Participant Flow
On September 12, 2024, Oncternal Therapeutics, Inc. announced its decision to discontinue the clinical trial evaluating ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma. The study only enrolled the first few patients into the Phase 1 portion of the study and did not reach a RP2D recommendation. Hence, the Phase 2 portion of the study was not conducted.
Participant milestones
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
4
|
|
Overall Study
Received ONCT-808 One-time Infusion
|
3
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
Overall Study
Sponsor Decision
|
2
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Screen Fail
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies
Baseline characteristics by cohort
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
n=3 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
n=2 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
n=4 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after the one-time infusion of ONCT-808Population: DLT-evaluable population
This is based on subject treated with ONCT-808. ONCT-808 1x10\^6 CAR T cells/kg: n=3 ONCT-808 3x10\^6 CAR T cells/kg: n=1 ONCT-808 0.3x10\^6 CAR T cells/kg: n=2
Outcome measures
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
n=3 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
n=1 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
n=2 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
To Evaluate the Incidence of Dose Limiting Toxicities (DLT)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 1 year after the one-time infusion of ONCT-808Population: Efficacy evaluable population
This is based on subject treated with ONCT-808. ONCT-808 1x10\^6 CAR T cells/kg: n=3 ONCT-808 3x10\^6 CAR T cells/kg: n=1 ONCT-808 0.3x10\^6 CAR T cells/kg: n=2 Response assessments were evaluated using fluorodeoxyglucose (FDG) positron-emission tomography-computed tomography (PET-CT) per the Lugano classification (Cheson, 2014)
Outcome measures
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
n=3 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
n=1 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
n=2 Participants
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
Best Metabolic Response Rate Post-Baseline
Complete Metabolic Response
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Best Metabolic Response Rate Post-Baseline
Partial Metabolic Response
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Metabolic Response Rate Post-Baseline
Not Done (i.e., response assessment was not conducted)
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
ONCT-808 1x10^6 CAR T Cells/kg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
ONCT-808 3x10^6 CAR T Cells/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
ONCT-808 0.3x10^6 CAR T Cells/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
n=3 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
n=1 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
n=2 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/3 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Infections and infestations
Anal Abscess
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Infections and infestations
Bacterial Spesis
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Immune system disorders
Cytokine Release Syndrome
|
33.3%
1/3 • Number of events 2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Nervous system disorders
Encenphalopathy
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Nervous system disorders
ICANS
|
0.00%
0/3 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Cardiac disorders
Pericardial Effusion
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Infections and infestations
Pneumonia
|
66.7%
2/3 • Number of events 4 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Vascular disorders
Shock
|
0.00%
0/3 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Cardiac disorders
Systolic Dysfunction
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
Other adverse events
| Measure |
ONCT-808 1x10^6 CAR T Cells/kg
n=3 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 3x10^6 CAR T Cells/kg
n=1 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
ONCT-808 0.3x10^6 CAR T Cells/kg
n=2 participants at risk
ONCT-808 consists of autologous CD3/CD28 activated CD4 and CD8 T cells transduced with lentivirus vector expressing a chimeric antigen receptor (CAR) containing a Receptor-tyrosine kinase like Orphan Receptor 1 (ROR1)-directed scFv from zilovertamab (humanized antibody previously known as cirmtuzumab or UC-961) with 4-1BB and CD3 ζ signaling domains
|
|---|---|---|---|
|
Immune system disorders
Cytokine Release Syndrome
|
66.7%
2/3 • Number of events 5 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
2/2 • Number of events 2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
0.00%
0/1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
2/2 • Number of events 2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
1/1 • Number of events 2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
100.0%
2/2 • Number of events 2 • AEs collected within 1 year from the date of the one-time infusion of ONCT-808.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place