LeukemiaCS22-03NCT05784415
Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell
An observational study of Leukemia and Leukemia, Lymphoblastic, run by AIDS Malignancy Consortium at 1 site in United States.
Trial summary
This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this protocol, sites will be asked to capture information of participants, who carry a diagnosis of HIV disease AND received CAR19 therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Leukemia, Lymphoblastic, Lymphoma, Large B-Cell, Diffuse
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2021to 14 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV treated with CD19-directed CAR T cell therapy for B-cell lymphoid malignancies
Who may be able to join
- Documented history of HIV infection
- Received CD19-directed CAR T cell therapy for acute lymphoblastic leukemia, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal B-cell lymphoma
- Age ≥ 18 years
Who cannot join
- Prior treatment with any CAR T cell therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
About this study
Official title: Observational Cohort Study of People Living With HIV Treated With CD19-directed CAR T Cell Therapy for B-cell Lymphoid Malignancies
This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this protocol, sites will be asked to capture information of participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 30, 2023. Data captured will include data points are available as part of standard of care for participants undergoing CAR19 therapy. AMC investigators, as well as non-AMC investigators will identify eligible participants to the CIBMTR, who in turn will provide the AMC statistical center with de-identified data
Read the detailed description
Two landmark trials have led to the FDA approval of two different CD19 directed chimeric antigen receptor (CAR) T cell (CAR19) products in the United States for the treatment of relapsed or refractory (RR) large B-cell lymphoma after two or more lines of systemic therapy: tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta ®). In the ZUMA-1 registration trial for axicabtagene ciloleucel (axi-cel), 42% of the 101 treated patients achieved a complete response (CR), and with a median follow up of 15 months, the projected 1year progression free survival (PFS) was 70%. In a recent updated analysis, the CR rate was 58% with about 40% of patients having durable remissions at 2 years of follow up. Similar results were seen in the JULIET registrational trial for tisagenlecleucel (tisa-cel) with an overall response rate (ORR) of 52%, and a CR rate of 40% in the 93 patients evaluable for response; with a median follow up of 14 months, the estimated 12-months relapse-free survival was 65% (79% among patients with a CR). Tisagenlecleucel is also approved for the treatment of acute B-lineage lymphoblastic leukemia in patients up to the age of 25 years. Unfortunately, in both trials patients with known HIV infection were excluded. Therefore, no safety or efficacy data for treatment with CAR19 in PLWH exists, and access for PLWH in the US to this potentially curative treatment has been limited.
This has to be contrasted with the fact that malignancies, and specifically lymphomas, remain a major contributor to early mortality in PLWH. With a lifetime risk of cancer ranging between 24-40%, the leading cause of death in PLWH in economically developed countries is cancer, and the most common cancer in PLWH in the US remains Non-Hodgkin lymphoma (NHL). While early during the HIV epidemic, outcomes for PLWH and aggressive B-cell lymphomas were significantly worse compared to immunocompetent patients, this is no longer the case for the majority of PLWH, owing mainly to effective antiretroviral therapies leading to better tolerance of myelosuppressive chemotherapy and a consequent paradigm shift in aggressive therapies for HIV-associated lymphoma. It has been repeatedly demonstrated that PLWH have been able to safely tolerate aggressive high-dose chemotherapy, as well as autologous and even allogeneic hematopoietic cell transplant.
- Conditions
- Leukemia, Leukemia, Lymphoblastic, Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular
- Keywords
- B-cell lymphoma, acute lymphoblastic leukemia, CART cell therapy, CAR T-cell therapy
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, HIV Infections, Lymphoma, Primary Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Clinical information on participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 31, 2021 will be captured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Toxicities Related to CAR19 Therapy
Toxicities related to CAR19 therapy will be reported by Common Terminology for Adverse Events (CTCAE) criteria, as well as American Society for Transplantation and Cellular Therapy (ASTCT) criteria (for cytokine release syndrome). Maximum neurotoxicity will be reported. Grade 1 indicates a mild adverse event; Grade 2 indicates a moderate adverse event; Grade 3 indicates a severe adverse event; Grade 4 indicates life-threatening adverse event; and Grade 5 indicates death.
Measured: 12 months
Secondary outcomes (14)
Overall Response
Overall response is defined as complete remission (CR) plus partial remission (PR) based on response assessment using the Lugano criteria.
Measured: 3 months and 6 months
Complete Remission
Complete remission is defined as complete disappearance of all disease based on response assessment using the Lugano criteria.
Measured: 3 months
CD8 Count at 3 Months Post CAR-T
CD8 count measured at 3 months post CAR-T will be reported
Measured: 3 months post CAR-T
CD8 Count at 6 Months Post CAR-T
CD8 count measured at 6 months post CAR-T will be reported.
Measured: 6 months post CAR-T
CD8 Count at 9 Months Post-CAR T
CD8 count measured at 9 months post CAR-T will be reported.
Measured: 9 months post-CAR T
CD8 Count at 12 Months Post-CAR T
CD8 count measured at 12 months post CAR-T will be reported.
Measured: 12 months post-CAR T
HIV Viral Load at 3 Months Post-CAR T
HIV viral load measured at 3 months post CAR-T will be reported.
Measured: 3 months post CAR-T
HIV Viral Load at 6 Months Post-CAR T
HIV viral load measured at 6 months post CAR-T will be reported.
Measured: 6 months post CAR-T
HIV Viral Load at 9 Months Post-CAR T
HIV viral load measured at 9 months post CAR-T will be reported.
Measured: 9 months post CAR-T
HIV Viral Load at 12 Months Post-CAR T
HIV viral load measured at 12 months post CAR-T will be reported.
Measured: 12 months post CAR-T
Neutrophil Recovery
Neutrophil recovery is defined as when ANC is greater than or equal to 500 per mm3 achieved and sustained for 3 lab values. The number of participants who experience neutrophil recovery will be reported.
Measured: 12 months after CAR-T
Platelet Recovery
Platelet recovery is defined as when platelet counts are greater than or equal to 20x10^9 per L. The number of participants who experience platelet recovery will be reported.
Measured: 12 months after CAR-T
Overall Survival
Overall survival is defined as the elapsed time between HCT and the date of death.
Measured: Up to 2 years
Progression-free Survival
Progression-free survival is defined as elapsed time between HCT and disease progression or death from any cause. If a participant receives subsequent HCT, this participant will be censored as date of subsequent HCT.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start22 May 2021
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- Center for International Blood and Marrow Transplant Research
- Responsible party
- Sponsor
- Investigators
- Stefan Barta, MD, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784415
- Sponsor's protocol ID
- AMC-113
- Acronym
- CS22-03
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2023
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of People Living With HIV Treated With CD19-directed CAR T Cell Therapy for B-cell Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT05784415
- Acronym / sponsor ID
- CS22-03 / AMC-113
- Conditions
- Leukemia, Leukemia, Lymphoblastic, Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular
- Keywords
- B-cell lymphoma, acute lymphoblastic leukemia, CART cell therapy, CAR T-cell therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- Center for International Blood and Marrow Transplant Research
- Study start
- 22 May 2021 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this protocol, sites will be asked to capture information of participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 30, 2023. Data captured will include data points are available as part of standard of care for participants undergoing CAR19 therapy. AMC investigators, as well as non-AMC investigators will identify eligible participants to the CIBMTR, who in turn will provide the AMC statistical center with de-identified data
Detailed description
Two landmark trials have led to the FDA approval of two different CD19 directed chimeric antigen receptor (CAR) T cell (CAR19) products in the United States for the treatment of relapsed or refractory (RR) large B-cell lymphoma after two or more lines of systemic therapy: tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta ®). In the ZUMA-1 registration trial for axicabtagene ciloleucel (axi-cel), 42% of the 101 treated patients achieved a complete response (CR), and with a median follow up of 15 months, the projected 1year progression free survival (PFS) was 70%. In a recent updated analysis, the CR rate was 58% with about 40% of patients having durable remissions at 2 years of follow up. Similar results were seen in the JULIET registrational trial for tisagenlecleucel (tisa-cel) with an overall response rate (ORR) of 52%, and a CR rate of 40% in the 93 patients evaluable for response; with a median follow up of 14 months, the estimated 12-months relapse-free survival was 65% (79% among patients with a CR). Tisagenlecleucel is also approved for the treatment of acute B-lineage lymphoblastic leukemia in patients up to the age of 25 years. Unfortunately, in both trials patients with known HIV infection were excluded. Therefore, no safety or efficacy data for treatment with CAR19 in PLWH exists, and access for PLWH in the US to this potentially curative treatment has been limited.
This has to be contrasted with the fact that malignancies, and specifically lymphomas, remain a major contributor to early mortality in PLWH. With a lifetime risk of cancer ranging between 24-40%, the leading cause of death in PLWH in economically developed countries is cancer, and the most common cancer in PLWH in the US remains Non-Hodgkin lymphoma (NHL). While early during the HIV epidemic, outcomes for PLWH and aggressive B-cell lymphomas were significantly worse compared to immunocompetent patients, this is no longer the case for the majority of PLWH, owing mainly to effective antiretroviral therapies leading to better tolerance of myelosuppressive chemotherapy and a consequent paradigm shift in aggressive therapies for HIV-associated lymphoma. It has been repeatedly demonstrated that PLWH have been able to safely tolerate aggressive high-dose chemotherapy, as well as autologous and even allogeneic hematopoietic cell transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Clinical information on participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 31, 2021 will be captured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV treated with CD19-directed CAR T cell therapy for B-cell lymphoid malignancies
Key inclusion criteria (3 listed)
- Documented history of HIV infection
- Received CD19-directed CAR T cell therapy for acute lymphoblastic leukemia, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal B-cell lymphoma
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Prior treatment with any CAR T cell therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Toxicities Related to CAR19 Therapy
Time frame: 12 months
Toxicities related to CAR19 therapy will be reported by Common Terminology for Adverse Events (CTCAE) criteria, as well as American Society for Transplantation and Cellular Therapy (ASTCT) criteria (for cytokine release syndrome). Maximum neurotoxicity will be reported. Grade 1 indicates a mild adverse event; Grade 2 indicates a moderate adverse event; Grade 3 indicates a severe adverse event; Grade 4 indicates life-threatening adverse event; and Grade 5 indicates death.
14 secondary outcomes
Overall Response
Time frame: 3 months and 6 months
Complete Remission
Time frame: 3 months
CD8 Count at 3 Months Post CAR-T
Time frame: 3 months post CAR-T
CD8 Count at 6 Months Post CAR-T
Time frame: 6 months post CAR-T
CD8 Count at 9 Months Post-CAR T
Time frame: 9 months post-CAR T
CD8 Count at 12 Months Post-CAR T
Time frame: 12 months post-CAR T
HIV Viral Load at 3 Months Post-CAR T
Time frame: 3 months post CAR-T
HIV Viral Load at 6 Months Post-CAR T
Time frame: 6 months post CAR-T
HIV Viral Load at 9 Months Post-CAR T
Time frame: 9 months post CAR-T
HIV Viral Load at 12 Months Post-CAR T
Time frame: 12 months post CAR-T
Neutrophil Recovery
Time frame: 12 months after CAR-T
Platelet Recovery
Time frame: 12 months after CAR-T
Overall Survival
Time frame: Up to 2 years
Progression-free Survival
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Barta, MD principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Leukemia, Lymphoblastic, run by AIDS Malignancy Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Toxicities Related to CAR19 Therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.