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| ID | Type | Description | Link |
|---|---|---|---|
| SU-09142011-8407 | Other Identifier | Stanford University | |
| BMT236 | Other Identifier | OnCore | |
| 1R01HL114591-01 | U.S. NIH Grant/Contract | View source | |
| NCI-2011-03025 | Registry Identifier | National Cancer Institute Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Phase I: Low Dose Treg + Tcon (Dose escalation) | Experimental | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC. |
|
| Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose escalation) | Experimental | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC. |
|
| Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose escalation) | Experimental | Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen. |
|
| Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose escalation) | Active Comparator | Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD34+ Hematopoietic Progenitor Cells (HSPC) | Biological | Purified CD34+ hematopoietic progenitor cells used in transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| GvHD Free Relapse Free Survival (GRFS) | GvHD-free is defined as no GvHD symptoms, and relapse free survival is defined as survival at 12 months without relapse. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) Within 28 Days | Dose-limiting Toxicity (DLT) was assessed as:
|
Not provided
Recipient Inclusion Criteria
Patients with the following diseases that are histopathologically confirmed are eligible
Acute leukemia, primary refractory or beyond CR1, or minimal residual disease (MRD) positivity.
High risk acute myeloid leukemia in CR1 with any of the following features:
Complex karyotype(≥3 clonal chromosomal abnormalities)
Any of the following high risk chromosomal abnormalities:
Other high risk features as determined by molecular studies, or clinical presentation as assessed by the treating physician
Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
Myelodysplastic syndromes
Myeloproliferative syndromes
Non-Hodgkin lymphoma with poor risk features not suitable for autologous HCT
Age ≥18 yo and ≤ 60 yo for patients in Cohort 1 only. At the start of Cohort 2A and beyond, eligibility will be expanded to allow pediatric patients age ≥ 13 yo.
Cardiac ejection fraction ≥ 45%
Lung diffusion capacity ≥ 50%
Calculated creatinine clearance ≥ 50 cc/min
Serum glutamic-pyruvic transaminase( SGPT) and serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3.0 x ULN (Upper limit of normal), unless elevated secondary to disease.
Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or where hemolysis has been excluded
Availability of a HLA matched donor (related or unrelated) defined by Class I (HLA-A and B) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular typing. An HLA matched donor is defined for this study to be a sibling that is HLA matched 6/6; or an unrelated donor that is HLA matched 6/6 or 5/6. A sibling may be a "half sibling."
Karnofsky performance status ≥70%
Recipient Exclusion Criteria
Seropositive for any of the following:
HIV ab; hepatitis B sAg; hepatitis C ab
Prior myeloablative therapy or hematopoietic cell transplant
Candidate for autologous transplant
HIV positive
Active uncontrolled bacterial, viral or fungal infection, defined as currently taking antimicrobial therapy and progression of clinical symptoms.
Uncontrolled central nervous system (CNS) disease involvement
Pregnant or a lactating female
Positive serum or urine beta human chorionic gonadotropin (HCG) test in females of childbearing potential within 3 weeks of registration
Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care
Donor Inclusion Criteria
Age ≥13 yo and ≤ 75 years
Karnofsky performance status of ≥ 70% defined by institutional standards
Seronegative for HIV 1 RNA (polymerase chair reaction (PCR); HIV 1 and HIV 2 ab (antibody); HTLV 1 and HTLV 2 ab; PCR+ or sAg (surface antigen) hepatitis B ; or PCR+ or sAg for hepatitis C; negative for the Treponema pallidum antibody Syphilis screen; and negative for HIV 1 and hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection. In the case that T pallidum antibody tests are positive, donors must:
Must be 6/6 matched sibling donor as determined by HLA typing
Female donors of child-bearing potential must have a negative serum or urine beta-HCG test within three weeks of mobilization
Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Agreeable to 2nd donation of Peripheral blood stem cell (PBPC) (or bone marrow harvest) in the event of graft failure
The donor or legal guardian greater than 18 years of age, capable of signing an institutional review board (IRB-approved consent form.
Donor Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Everett Meyer | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine Palo Alto, California, United States | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39792934 | Derived | Meyer EH, Pavlova A, Villar-Prados A, Bader C, Xie B, Muffly L, Kim P, Sutherland K, Bharadwaj S, Dahiya S, Frank M, Arai S, Johnston L, Miklos D, Rezvani A, Shiraz P, Sidana S, Shizuru J, Weng WK, Agrawal V, Putnam A, Fernhoff N, Tamarisis J, Lu Y, Pawar RD, McClellan JS, Lowsky R, Negrin RS. Donor regulatory T-cell therapy to prevent graft-versus-host disease. Blood. 2025 May 1;145(18):2012-2024. doi: 10.1182/blood.2024026446. | |
| 38091578 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm/Group Title Cohort 1, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2022 |
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| Cohort 3, Phase I: High Dose Treg + Tcon (Dose escalation) | Experimental | Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. |
|
| Cohort 3A, Phase I: High Dose Treg + Tcon (Dose escalation) | Experimental | Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen. |
|
| Phase 2: Myeloablative HCT Control | Active Comparator | Participants receive standard myeloablative conditioning with CD34+ HSPC and no experimental Treg or Tcon. |
|
| Phase 2 Treg + Tcon with Immunosuppression | Experimental | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
| Phase 2 Treg + Tcon without Immunosuppression | Experimental | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. |
|
| Regulatory T-Cells (Treg) | Biological | Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. |
|
| Conventional T-Cells (Tcon) | Biological | Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
|
| Myeloablative Conditioning Regimen | Procedure | Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
|
| 28 days |
| Number of Participants With Overall Survival (OS) at 1 Year | Overall Survival (OS) at 1 year was assessed as the number of participants per treatment level that received the hematopoietic cell transplant (HCT), and remained alive 12 months later. | 1 year |
| Number of Participants With Severity of Chronic Graft-vs-Host Disease (cGvHD) at 24 Months | Incidence and severity of chronic GvHD was assessed in participants who received the hematopoietic cell transplant (HCT) at 24 months. | 2 years |
| Number of Participants With Incidence of Serious Infections | The outcome is reported as the number of serious infections per treatment level, in participants who received the hematopoietic cell transplant (HCT). | 24 months |
| Number of Participants Receiving Concomitant Single-Agent Immunosuppression | During Phase 2, stage 1, concomitant single-agent immunosuppression was assessed as in participants receiving fresh Treg cells. | 2 years |
| Bader CS, Pavlova A, Lowsky R, Muffly LS, Shiraz P, Arai S, Johnston LJ, Rezvani AR, Weng WK, Miklos DB, Frank MJ, Tamaresis JS, Agrawal V, Bharadwaj S, Sidana S, Shizuru JA, Fernhoff NB, Putnam A, Killian S, Xie BJ, Negrin RS, Meyer EH. Single-center randomized trial of T-reg graft alone vs T-reg graft plus tacrolimus for the prevention of acute GVHD. Blood Adv. 2024 Mar 12;8(5):1105-1115. doi: 10.1182/bloodadvances.2023011625. |
| 31092732 | Derived | Meyer EH, Laport G, Xie BJ, MacDonald K, Heydari K, Sahaf B, Tang SW, Baker J, Armstrong R, Tate K, Tadisco C, Arai S, Johnston L, Lowsky R, Muffly L, Rezvani AR, Shizuru J, Weng WK, Sheehan K, Miklos D, Negrin RS. Transplantation of donor grafts with defined ratio of conventional and regulatory T cells in HLA-matched recipients. JCI Insight. 2019 May 16;4(10):e127244. doi: 10.1172/jci.insight.127244. eCollection 2019 May 16. |
| FG001 | Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
| FG002 | Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG003 | Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG004 | Cohort 3, Phase I: High Dose Treg + Tcon (Dose Escalation) | Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG005 | Cohort 3A, Phase I: High Dose Treg + Tcon (Dose Escalation) | Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG006 | Phase 2, Stage 1 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG007 | Phase 2, Stage 1 Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| FG008 | Phase 2, Stage 2 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graftversus- host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation |
| Day +28 Completed |
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| 12-Month Follow-Up Completed |
|
| 24-Month Follow-Up Completed |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
| BG001 | Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
| BG002 | Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| BG003 | Phase 2 , Stage 1 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| BG004 | Phase 2, Stage 1 Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
| BG005 | Phase 2, Phase 2 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graftversus- host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | GvHD Free Relapse Free Survival (GRFS) | GvHD-free is defined as no GvHD symptoms, and relapse free survival is defined as survival at 12 months without relapse. | Posted | Count of Participants | Participants | 12 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose-Limiting Toxicity (DLT) Within 28 Days | Dose-limiting Toxicity (DLT) was assessed as:
| Posted | Count of Participants | Participants | 28 days |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Survival (OS) at 1 Year | Overall Survival (OS) at 1 year was assessed as the number of participants per treatment level that received the hematopoietic cell transplant (HCT), and remained alive 12 months later. | Posted | Count of Participants | Participants | 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Severity of Chronic Graft-vs-Host Disease (cGvHD) at 24 Months | Incidence and severity of chronic GvHD was assessed in participants who received the hematopoietic cell transplant (HCT) at 24 months. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Incidence of Serious Infections | The outcome is reported as the number of serious infections per treatment level, in participants who received the hematopoietic cell transplant (HCT). | Posted | Count of Participants | Participants | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Receiving Concomitant Single-Agent Immunosuppression | During Phase 2, stage 1, concomitant single-agent immunosuppression was assessed as in participants receiving fresh Treg cells. | Posted | Count of Participants | Participants | 2 years |
|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. | 1 | 1 | 1 | 1 | 0 | 1 |
| EG001 | Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. | 3 | 5 | 2 | 5 | 4 | 5 |
| EG002 | Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose Escalation) | Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. | 2 | 6 | 6 | 6 | 6 | 6 |
| EG003 | Phase 2, Staage 1 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. | 3 | 12 | 2 | 12 | 11 | 12 |
| EG004 | Phase 2, Stage 1 Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation. | 2 | 12 | 6 | 12 | 11 | 12 |
| EG005 | Phase 2, Stage 2 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. CD34+ Hematopoietic Progenitor Cells (HSPC): Purified CD34+ hematopoietic progenitor cells used in transplantation. Regulatory T-Cells (Treg): Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graftversus- host disease. Conventional T-Cells (Tcon): Conventional CD3+ T cells used for immune reconstitution and graft enhancement. Myeloablative Conditioning Regimen: Chemotherapy or total body irradiation used before hematopoietic cell transplantation | 6 | 32 | 10 | 32 | 25 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| CML relapse | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Graft failure | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute GI and Liver GVHD | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Acute cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Gallbladder obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver GVHD | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus infection reactivation | Infections and infestations | Systematic Assessment |
| ||
| Epstein-Barr Infection reactivation | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex reactivation | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Rhizomucor/aspergillus/rhizopus | Infections and infestations | Systematic Assessment |
| ||
| Hemorrhagic cystitis | Infections and infestations | Systematic Assessment |
| ||
| Transaminitis | Infections and infestations | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
| ||
| Altered mental status | Nervous system disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure secondary to pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Rash maculopapular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin GVHD | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hematoma of the bladder | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypertension | Vascular disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Elevated INR | Investigations | Systematic Assessment |
| ||
| Transminitis | Investigations | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| White blood cell decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Periorbital Edema (retinal hemorrhage) | Eye disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distention | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting (Emesis) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| GI GVHD | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Dysuria | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Epistaxis | General disorders | Systematic Assessment |
| ||
| Hypothermia | General disorders | Systematic Assessment |
| ||
| Limb edema | General disorders | Systematic Assessment |
| ||
| Blast crisis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis (Thrush) | Infections and infestations | Systematic Assessment |
| ||
| Streptococcus mitis bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
| ||
| E coli bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Colonic fistula | Infections and infestations | Systematic Assessment |
| ||
| Clostridioides difficile | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| rhinovirus | Infections and infestations | Systematic Assessment |
| ||
| BK virus | Infections and infestations | Systematic Assessment |
| ||
| HSV1 | Infections and infestations | Systematic Assessment |
| ||
| Coag negative staphylococcus aureus bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Epstein-Barr virus | Infections and infestations | Systematic Assessment |
| ||
| parainfluenza | Infections and infestations | Systematic Assessment |
| ||
| fungal pneumonia | Infections and infestations | Systematic Assessment |
| ||
| invasive fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex reactivation | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Systematic Assessment |
| ||
| HHV6 Viremia | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other- Thigh pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Anosmia | Nervous system disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Cystitis | Renal and urinary disorders | Systematic Assessment |
| ||
| Vaginal pruritis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chylothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hiccups | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Generalized edema | Vascular disorders | Systematic Assessment |
| ||
| DVT | Vascular disorders | Systematic Assessment |
| ||
| swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Acute skin GVHD | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Aspergillus | Infections and infestations | Systematic Assessment |
| ||
| bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus (CMV) infection | Infections and infestations | Systematic Assessment |
| ||
| syncope | General disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Blood bilirubin increase | Hepatobiliary disorders | Systematic Assessment |
| ||
| Erythematous rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| hyperparathyroidism | Endocrine disorders | Systematic Assessment |
| ||
| platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Everett Meyer | Stanford University | 650-725-5816 | evmeyer@stanford.edu |
| Mar 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
Not provided
Not provided
| 30 - 39 |
|
| 40 - 49 |
|
| 50 - 59 |
|
| equal or less than 60 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose Escalation) |
Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen. |
| OG003 | Phase 2, Stage 1: Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
| OG004 | Phase 2, Stage 1: Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. |
| OG005 | Phase 2, Phase 2 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
|
| OG004 | Phase 2, Stage 1: Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. |
| OG005 | Phase 2, Stage 2: Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
|
| OG004 | Phase 2, Stage 1: Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. |
| OG005 | Phase 2, Stage 2: Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
|
| OG004 | Phase 2, Stage 2: Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
| OG005 | Phase 2, Phase 2 Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
|
| OG004 | Phase 2, Stage 1: Treg + Tcon Without Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning. |
| OG005 | Phase 2, Stage 2: Treg + Tcon With Immunosuppression (Cohort 2A) | Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning. |
|
|