Cluster of Differentiation Antigen 19/22(CD19/22) CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma
NCT ID: NCT03287817
Last Updated: 2025-07-14
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
52 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-05
Study Completion Date
2023-10-19
Brief Summary
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The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 with consolidation or pre-conditioning with anti-PD1 antibody in patients with DLBCL
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Detailed Description
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The study will consist of 2 phases, a Phase I or dose escalation and expansion phase, and a Phase II. Patients with relapsed or refractory DLBCL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3, a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO 3 intravenously as a single dose and in addition a limited duration of treatment with an anti-PD1 antibody (either as part of the pre-conditioning regimen or consolidation). Patients will then enter a 36-month follow-up period.
Conditions
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Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
A dose escalation and expansion phase (Phase I) followed by Phase II
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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AUTO3
Patient with relapsed or refractory DLBCL
Group Type
EXPERIMENTAL
AUTO3
Intervention Type
BIOLOGICAL
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 900 x 10⁶ CD19/ CD22 Chimeric Antigen Receptor (CAR) positive T cells with limited duration of anti-PD1 antibody (pembrolizumab).
Interventions
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AUTO3
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 900 x 10⁶ CD19/ CD22 Chimeric Antigen Receptor (CAR) positive T cells with limited duration of anti-PD1 antibody (pembrolizumab).
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Male or female, aged ≥18 years.
2. Willing and able to give written, informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
4. Histologically confirmed DLBCL and large B cell lymphoma subsets, including:
Phase I and Phase II Cohort 1:
1. DLBCL, not otherwise specified (NOS), per World Health Organisation classification and DLBCL with MYC oncogene (MYC) and B cell lymphoma 2 (BCL2) gene and/or B cell lymphoma 6 (BCL6) gene rearrangements (double/triple hit).
2. Transformed DLBCL from follicular lymphoma (FL).
3. High-grade B cell lymphoma with MYC expression (excluding Burkitt's lymphoma) Phase I and Phase II Cohort 2.
4. Transformed DLBCL from other indolent lymphomas (excluding Richter's transformation).
5. Primary mediastinal large B cell lymphoma.
5. Chemotherapy-refractory disease, defined as one or more of the following:
1. Stable disease (≤12 months) or progressive disease as best response to most recent chemotherapy containing regimen. Refractory disease after frontline chemo-immunotherapy is allowed.
2. Disease progression or recurrence in ≤12 months of prior autologous haematopoietic stem cell transplantation (ASCT).
OR
6. Relapse after ≥two lines of therapy or after ASCT. At a minimum:
1. Patients must have received rituximab or another anti-cluster of differentiation antigen 20 (CD20) monoclonal antibody (unless Investigator determines that tumour is CD20-negative) and an anthracycline-containing chemotherapy regimen.
2. Patients must have either failed ASCT, or be ineligible for or not consenting to ASCT.
3. Patients with transformed DLBCL must have received at least one line of therapy after transformation to DLBCL.
7. Positron emission tomography-positive disease per Lugano classification.
8. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment.
For females who are not postmenopausal or surgically sterile, highly effective methods of contraception must be used during the treatment period and for at least 12 months after the last dose of study treatment.
9. For males, it must be agreed that that two acceptable methods of contraception are used.
10. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
1. Creatinine clearance ≥40 cc/min.
2. Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).
3. Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.
4. Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \[ECHO\] or Multiple gated acquisition scan \[MUGA\]) unless the institutional lower limit of normal is lower.
5. Baseline oxygen saturation \>92% on room air and ≤Grade 1 dyspnoea.
11. Patient has adequate bone marrow (BM) function without requiring ongoing blood product or granulocyte-colony stimulating factor support and meets the following criteria:
1. Absolute neutrophil count ≥1.0 × 10\^9/L.
2. Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis).
3. Haemoglobin ≥80 g/L.
4. Platelets ≥75 × 10\^9/L
12. No contra-indications for leukapheresis.
2. Willing and able to give written, informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
4. Histologically confirmed DLBCL and large B cell lymphoma subsets, including:
Phase I and Phase II Cohort 1:
1. DLBCL, not otherwise specified (NOS), per World Health Organisation classification and DLBCL with MYC oncogene (MYC) and B cell lymphoma 2 (BCL2) gene and/or B cell lymphoma 6 (BCL6) gene rearrangements (double/triple hit).
2. Transformed DLBCL from follicular lymphoma (FL).
3. High-grade B cell lymphoma with MYC expression (excluding Burkitt's lymphoma) Phase I and Phase II Cohort 2.
4. Transformed DLBCL from other indolent lymphomas (excluding Richter's transformation).
5. Primary mediastinal large B cell lymphoma.
5. Chemotherapy-refractory disease, defined as one or more of the following:
1. Stable disease (≤12 months) or progressive disease as best response to most recent chemotherapy containing regimen. Refractory disease after frontline chemo-immunotherapy is allowed.
2. Disease progression or recurrence in ≤12 months of prior autologous haematopoietic stem cell transplantation (ASCT).
OR
6. Relapse after ≥two lines of therapy or after ASCT. At a minimum:
1. Patients must have received rituximab or another anti-cluster of differentiation antigen 20 (CD20) monoclonal antibody (unless Investigator determines that tumour is CD20-negative) and an anthracycline-containing chemotherapy regimen.
2. Patients must have either failed ASCT, or be ineligible for or not consenting to ASCT.
3. Patients with transformed DLBCL must have received at least one line of therapy after transformation to DLBCL.
7. Positron emission tomography-positive disease per Lugano classification.
8. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment.
For females who are not postmenopausal or surgically sterile, highly effective methods of contraception must be used during the treatment period and for at least 12 months after the last dose of study treatment.
9. For males, it must be agreed that that two acceptable methods of contraception are used.
10. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
1. Creatinine clearance ≥40 cc/min.
2. Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).
3. Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.
4. Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \[ECHO\] or Multiple gated acquisition scan \[MUGA\]) unless the institutional lower limit of normal is lower.
5. Baseline oxygen saturation \>92% on room air and ≤Grade 1 dyspnoea.
11. Patient has adequate bone marrow (BM) function without requiring ongoing blood product or granulocyte-colony stimulating factor support and meets the following criteria:
1. Absolute neutrophil count ≥1.0 × 10\^9/L.
2. Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis).
3. Haemoglobin ≥80 g/L.
4. Platelets ≥75 × 10\^9/L
12. No contra-indications for leukapheresis.
Exclusion Criteria
1. Prior allogeneic haematopoietic stem cell transplant.
2. Females who are pregnant or lactating.
3. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
4. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to AUTO3 infusion).
5. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
1. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded).
2. Evidence of pericardial effusion
6. Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
7. Patients with active gastrointestinal bleeding.
8. Patients with any major surgical intervention in the last 3 months.
9. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
10. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.
11. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
12. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.
13. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
14. Prior treatment with PD1, programmed cell death ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated protein-4-targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists within 6 weeks prior to AUTO3 infusion.
15. Prior treatment with investigational or approved gene therapy or cell therapy products until a dose level has treated at least three patients and has been declared safe.
16. Prior CD19 or CD22 targeted therapy.
17. The following medications are excluded:
1. Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to AUTO3 administration. However, physiological replacement, topical, and inhaled steroids are permitted.
2. Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or AUTO3 infusion.
3. Cytotoxic chemotherapies within 2 weeks of AUTO3 infusion and 1 week prior to leukapheresis (2 weeks for lymphodepleting chemotherapy).
4. Antibody therapy use including anti-CD20 therapy within 2 weeks prior to AUTO3 infusion, or 5 half-lives of the respective antibody, whichever is shorter.
5. Granulocyte-colony stimulating factor less than 10 days prior to leukapheresis.
6. Live vaccine ≤4 weeks prior to enrolment.
7. Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.
18. Prior limited radiation therapy within 4 weeks of AUTO3 infusion or within 24 weeks for definitive radiation to chest.
19. Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
20. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine, pembrolizumab or tocilizumab.
21. Any contraindications to receive anti-PD1 antibody pembrolizumab will be excluded from cohorts requiring administration of pembrolizumab.
22. Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study.
23. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
Phase I outpatient cohort:
24. Subjects who do not have caregiver support (in line with institutional outpatient transplant guidelines) for outpatient/ambulatory care setting.
25. Subjects who are staying greater than 60 minutes (or whatever is permissible per institutional outpatient transplant guidelines) from the clinical trial site at the time of treatment.
1. Severe intercurrent infection.
2. Requirement for supplementary oxygen or active pulmonary infiltrates.
3. Clinical deterioration of organ function (renal and hepatic) exceeding the criteria set at study entry.
2. Females who are pregnant or lactating.
3. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
4. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to AUTO3 infusion).
5. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
1. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded).
2. Evidence of pericardial effusion
6. Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
7. Patients with active gastrointestinal bleeding.
8. Patients with any major surgical intervention in the last 3 months.
9. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
10. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.
11. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
12. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.
13. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
14. Prior treatment with PD1, programmed cell death ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated protein-4-targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists within 6 weeks prior to AUTO3 infusion.
15. Prior treatment with investigational or approved gene therapy or cell therapy products until a dose level has treated at least three patients and has been declared safe.
16. Prior CD19 or CD22 targeted therapy.
17. The following medications are excluded:
1. Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to AUTO3 administration. However, physiological replacement, topical, and inhaled steroids are permitted.
2. Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or AUTO3 infusion.
3. Cytotoxic chemotherapies within 2 weeks of AUTO3 infusion and 1 week prior to leukapheresis (2 weeks for lymphodepleting chemotherapy).
4. Antibody therapy use including anti-CD20 therapy within 2 weeks prior to AUTO3 infusion, or 5 half-lives of the respective antibody, whichever is shorter.
5. Granulocyte-colony stimulating factor less than 10 days prior to leukapheresis.
6. Live vaccine ≤4 weeks prior to enrolment.
7. Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.
18. Prior limited radiation therapy within 4 weeks of AUTO3 infusion or within 24 weeks for definitive radiation to chest.
19. Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
20. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine, pembrolizumab or tocilizumab.
21. Any contraindications to receive anti-PD1 antibody pembrolizumab will be excluded from cohorts requiring administration of pembrolizumab.
22. Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study.
23. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
Phase I outpatient cohort:
24. Subjects who do not have caregiver support (in line with institutional outpatient transplant guidelines) for outpatient/ambulatory care setting.
25. Subjects who are staying greater than 60 minutes (or whatever is permissible per institutional outpatient transplant guidelines) from the clinical trial site at the time of treatment.
1. Severe intercurrent infection.
2. Requirement for supplementary oxygen or active pulmonary infiltrates.
3. Clinical deterioration of organ function (renal and hepatic) exceeding the criteria set at study entry.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Autolus Limited
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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City of Hope Hospital
Duarte, California, United States
Site Status
Colorado Blood Cancer Institute at Presbyterian/St. Luke's Medical Center/Sarah Cannon Research Institute
Denver, Colorado, United States
Site Status
Sylvester Comprehensive Cancer Center / University of Miami
Miami, Florida, United States
Site Status
Siteman Cancer Center / Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
TriStar Centennial Medical Center /Sarah Cannon Research Institute
Nashville, Tennessee, United States
Site Status
St David's South Austin Medical Center /Sarah Cannon Research Institute
Austin, Texas, United States
Site Status
The Beatson West of Scotland Cancer Centre / Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Site Status
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Site Status
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Site Status
Countries
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United States
United Kingdom
References
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Roddie C, Lekakis LJ, Marzolini MAV, Ramakrishnan A, Zhang Y, Hu Y, Peddareddigari VGR, Khokhar N, Chen R, Basilico S, Raymond M, Vargas FA, Duffy K, Brugger W, O'Reilly MA, Wood L, Linch DC, Peggs KS, Bachier C, Budde EL, Lee Batlevi C, Bartlett N, Irvine D, Tholouli E, Osborne W, Ardeshna KM, Pule MA. Dual targeting of CD19 and CD22 with bicistronic CAR-T cells in patients with relapsed/refractory large B-cell lymphoma. Blood. 2023 May 18;141(20):2470-2482. doi: 10.1182/blood.2022018598.
Reference Type
RESULT
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004682-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AUTO3-DB1
Identifier Type: -
Identifier Source: org_study_id
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