NCT05784415

Brief 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 outside of a clinical trial between August 30, 2017 and August 31, 2021. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

March 13, 2023

Last Update Submit

January 29, 2026

Conditions

Lymphoma, Large B-Cell, DiffuseFollicular LymphomaLymphoma, B-CellLymphoma, FollicularLymphoma, Non-HodgkinHIV InfectionsHIV Associated LymphomaHIV Disease; LymphomaLeukemiaLeukemia, Lymphoblastic

Keywords

B-cell lymphomaacute lymphoblastic leukemiaCART cell therapyCAR T-cell therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (5)

  • Change in CD4 count

    Day 0, 3 months, 6 months, and 12 months post CAR19 therapy

  • Absolute lymphocyte count

    Day 0, 3 months, 6 months, and 12 months post CAR19 therapy

  • HIV viral load

    Day 0, 3 months, 6 months, and 12 months post CAR19 therapy

  • Overall response

    3 months and 6 months

  • Complete remission

    3 months and 6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People living with HIV treated with CD19-directed CAR T cell therapy for B-cell lymphoid malignancies

You may qualify if:

  • 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

You may not qualify if:

  • Prior treatment with any CAR T cell therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, B-CellLymphoma, Non-HodgkinHIV InfectionsLymphoma, Primary EffusionAcquired Immunodeficiency SyndromeLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesSlow Virus Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

May 22, 2021

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

US(1)