18 and older, any sex, with Hematopoietic and Lymphoid Cell Neoplasm or Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants That Experienced Adverse EventsPrimary· Within 35 days of receptor tyrosine kinase-like orphan receptor 1 positive chimeric antigen receptor-T cell infusion
Will be graded according to Common Terminology Criteria for Adverse Events. Outcome will be reported as a count of participants that experienced adverse events in each arm.
Group
Value
95% CI
Cohort A Dose Level 1
2
Cohort A Dose Level 2
1
Cohort B Dose Level 1
2
Cohort B Dose Level 2
3
Cohort B Dose Level 3
11
Cohort B Dose Level 4
2
Number of Participants With Persistence of Adoptively Transferred Receptor Tyrosine Kinase-like Orphan Receptor 1 Positive Chimeric Antigen Receptor-T CellsSecondary· Up to 28 days after the T cell infusion
Data should be collected for persistence of transferred T cells and descriptive statistics will be used to summarize the changes from baseline where possible. This outcome is reported as a count of participants who experienced persistence at Day 28.
Group
Value
95% CI
Cohort A Dose Level 1
2
Cohort A Dose Level 2
0
Cohort B Dose Level 1
2
Cohort B Dose Level 2
1
Cohort B Dose Level 3
0
Cohort B Dose Level 4
0
Number of Participants Biopsied With Detectable CD3 T-cellsSecondary· Up to 48 days post infusion
Samples of bone marrow, blood and other tissues (e.g. cerebral spinal fluid, tumor, thoracentesis fluid) will be collected from patients as clinically indicated. CD3 T-cells and their frequency/persistence will be detected by flow cytometry, polymerase chain reaction, and immunohistochemistry as appropriate. This outcome is reported as a count of participants who had detectable CD3 T-cells in their biopsy sample. The patients in Cohort A had a biopsy of their bone marrow. For the patients in Cohort B, biopsy location was dependent on site of disease per patient.
Group
Value
95% CI
Cohort A Dose Level 1
2
Cohort A Dose Level 2
0
Cohort B Dose Level 1
2
Cohort B Dose Level 2
1
Cohort B Dose Level 3
0
Cohort B Dose Level 4
0
Objective Response Rate of Complete Remission and Partial RemissionSecondary· Up to 1 year
Outcome will be reported as a count of participants in each arm that experienced complete remission and/or partial remission. For Patients with Acute lymphoblast leukemia (ALL), remission status will be determined by restaging of bone marrow and other involved sites by morphology, flow cytometry and molecular studies, as appropriate. For Patients with NSCLC and TNBC, tumor response and progression will be evaluated in this study using the international criteria proposed by RECIST Criteria. Target lesion responses will be described as (1) Complete response (CR): disappearance of all target lesi
Group
Value
95% CI
Cohort A Dose Level 1
0
Cohort A Dose Level 2
0
Cohort B Dose Level 1
0
Cohort B Dose Level 2
1
Cohort B Dose Level 3
0
Cohort B Dose Level 4
0
Progression Free SurvivalSecondary· Up to 1 year
Outcome will be reported as a count of participants in each arm that survived up to 1 year post-infusion (per patient) and did not progress. For patients with Acute lymphoblast leukemia (ALL), remission status will be determined by restaging of bone marrow and other involved sites by morphology, flow cytometry and molecular studies, as appropriate. For Patients with NSCLC and TNBC, tumor response and progression will be evaluated in this study using the international criteria proposed by RECIST Criteria. Target lesion responses will be described as (1) Complete response (CR): disappearance of
Group
Value
95% CI
Cohort A Dose Level 1
0
Cohort A Dose Level 2
0
Cohort B Dose Level 1
0
Cohort B Dose Level 2
0
Cohort B Dose Level 3
1
Cohort B Dose Level 4
0
Overall SurvivalSecondary· Up to 1 year
Data should be collected for efficacy of transferred T cells and descriptive statistics will be used to summarize the changes from baseline where possible. Outcome will be reported as a count of participants that survived up until the 1 year post-infusion (per patient) timepoint.
Group
Value
95% CI
Cohort A Dose Level 1
1
Cohort A Dose Level 2
1
Cohort B Dose Level 1
0
Cohort B Dose Level 2
1
Cohort B Dose Level 3
6
Cohort B Dose Level 4
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to one year following last infusion per patient.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I trial studies the side effects and best dose of genetically modified T-cell therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast cancer (TNBC) that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Genetically modified therapies, such as ROR1 specific chimeric antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and safely given back to the patient after conventional therapy. The "genetically modified" T-cells have genes added in the laboratory to make them recognize ROR1.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 31 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02706392.