Trial Outcomes & Findings for Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia (NCT NCT02770820)

Last Updated: 2021-10-29

Results Overview

Evidence and nature of toxicities will be measured according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.This is the number of participants who experienced at least one adverse event (SAE).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

12 months after the last infusion

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Autologous CD8 T Cells) Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	7
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Autologous CD8 T Cells) Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study Death	1
Overall Study Physician Decision	2

Baseline Characteristics

Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Autologous CD8 T Cells) n=7 Participants Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	63.21 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after the last infusion

Outcome measures

Outcome measures
Measure	Treatment (Autologous CD8 T Cells) n=7 Participants Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)	0 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Feasibility of generating TCR-transduced TN and TCM subsets for adoptive immunotherapy in a high-risk AML population. This is the proportion of subjects who sign the treatment consent, have a T cell product generated, and ultimately receive the study intervention.

Outcome measures

Outcome measures
Measure	Treatment (Autologous CD8 T Cells) n=7 Participants Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Feasibility of Subsets	6 Participants

PRIMARY outcome

Timeframe: 12 months after the last infusion

Comparison of the relative frequencies and duration of persistence of adoptively transferred TCRC4-transduced CD8+ polyclonal TCM and TN cells, and of TCRC4-transduced TEBV CD8+ cells in blood and at the primary tumor site(s). This is the number of participants whose blood samples displayed TCRC4-transduced CD8+ polyclonal TCM and TN cell Persistence in follow up.

Outcome measures

Outcome measures
Measure	Treatment (Autologous CD8 T Cells) n=7 Participants Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Number of Participants Whose Treatment Resulted in TCRC4-transduced CD8+ Polyclonal TCM and TN Cell Persistence.	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 years

Other adverse events

Other adverse events
Measure	Treatment (Autologous CD8 T Cells) n=7 participants at risk Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	28.6% 2/7 • Number of events 4 • Up to 12 months
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Up to 12 months
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • Up to 12 months
Investigations Lymphocyte count decreased	71.4% 5/7 • Number of events 10 • Up to 12 months
Investigations Neutrophil count decreased	42.9% 3/7 • Number of events 3 • Up to 12 months
Investigations Platelet count decreased	28.6% 2/7 • Number of events 2 • Up to 12 months
Investigations White blood cell count decreased	42.9% 3/7 • Number of events 3 • Up to 12 months
Metabolism and nutrition disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • Up to 12 months
Vascular disorders Hypertension	57.1% 4/7 • Number of events 4 • Up to 12 months

Additional Information

Dr. Aude Chapuis

FHCRC

Phone: 2066674369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place