Non-Hodgkin LymphomaPhase 1NCT07891468

huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers

A Phase 1 study testing huCART19-IL18-CD428z cells in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by University of Pennsylvania at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This research study is being conducted to evaluate an experimental drug called huCART19-IL18-CD428z cells in patients living with HIV who have been diagnosed with Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Acute Lymphoblastic Leukemia (ALL), and Richter's Transformation (RT). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia
What is being tested?: huCART19-IL18-CD428z cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Jan 2027to Dec 2042
Phase: Phase 1
Are there results?: Not yet: the study is under way

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

Who may be able to join

(1) Signed informed consent form.
(2) Male or female age ≥ 18 years.
(3) HIV-1 infection diagnosed in accordance with WHO and CDC guidelines.
(4) Patients with one of the following B-cell malignancies:
(a) Non-Hodgkin's Lymphoma (NHL)- including the following sub-types:
(i) Patients with any of the following large B-cell lymphoma diagnoses who are relapsed/refractory after at least 2 prior lines of appropriate therapy:

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(aa) Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS);
(bb) Primary Cutaneous DLBCL;
(cc) Primary Mediastinal (thymic) Large B-cell Lymphoma;
(dd) ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e., "Double or Triple Hit");
(ee) High-grade B-cell Lymphoma, NOS;
(ff) T-cell Rich B-cell Lymphoma; Transformed Follicular Lymphoma;
(gg) Any aggressive B-cell lymphoma arising from indolent lymphoma.
(b) Follicular Lymphoma (FL)- relapsed/refractory disease after at least 2 prior lines of systemic therapy (not including a single agent monoclonal antibody therapy).
(c) Mantle Cell Lymphoma- relapsed/refractory disease after at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Single agent monoclonal antibody therapy does not count towards prior lines of therapy.
(d) Marginal Zone Lymphoma- relapsed/refractory disease after at least 2 prior lines of appropriate therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Single agent monoclonal antibody therapy does not count towards prior lines of therapy.
(e) Chronic Lymphocytic Leukemia (CLL):
(i) Patients with relapsed/refractory disease after at least 2 prior lines of appropriate therapy; AND
(ii) Patients must have previously received or be intolerant to an approved BTK inhibitor and venetoclax, unless a BTK inhibitor or venetoclax is contraindicated.
(f) Richter's Transformation (RT; Large cell transformation of CLL)- Patients must be primary refractory or have received at least 1 prior line of treatment for Richter's Transformation.
(g) Acute Lymphoblastic Leukemia (ALL)- patients with 2nd or greater relapsed or refractory disease as defined by one of the following criteria:
(i) Recurrent disease in the blood or bone marrow identified morphologically, by IHC or flow; OR
(ii) Isolated CNS disease. Note: Patients with prior/current history of CNS3 disease will only be eligible for treatment if the CNS disease is responsive to therapy; OR
(iii) Recurrent extramedullary disease at other (non-CNS) sites if disease response can be assessed radiographically. Note: Patients with recurrent extramedullary disease do not need to have detectable blood or bone marrow involvement; OR
(iv) Any relapse after allogeneic SCT; OR
(v) Patients with refractory disease as defined by one of the following:
(aa) Failure to achieve remission (<5% bone marrow blasts or ongoing extramedullary or CNS disease) after 2 cycles of induction chemotherapy; OR
(bb) Patients that achieve remission but remain MRD+ after ≥2 cycles of induction chemotherapy.
(vi) Note: Chronic myeloid leukemia (CML) lymphoid blast crisis is considered a sub-type of relapsed B-ALL, thus will be encompassed in our definition of B-ALL throughout
(5) Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory.
(a) NHL Patients: Within 6 months of physician-investigator confirmation of eligibility as long as there has been no intervening CD19 directed therapy since expression confirmed. Results outside of this window may be used, if there is no accessible tumor site and the subject did not receive intervening CD19 directed therapy since CD19 expression was confirmed.
(b) CLL/RT/ALL Patients: At time of most recent relapse. If the subject has subsequently received CD19-directed therapy since this result was obtained, repeat testing must be performed to determine eligibility.
(6) Clinically stable on an antiretroviral therapy (ART) regimen, without changes within the 28 days prior to eligibility confirmation by a physician-investigator. No changes to the current ART regimen planned as confirmed by the participant's primary infectious disease physician.
(7) Viral Load ≤ 30 copies/mL by Hologic's Aptima® HIV-1 Quant Dx Assay within 30 days prior to physician-investigator confirmation of eligibility
(8) ECOG Performance Status that is either 0 or 1.
(9) Adequate organ function defined by the study protocol.
(10) Evidence of active disease within 12 weeks of physician-investigator confirmation of eligibility.
(11) Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
(a) Have no active GVHD and require no immunosuppression
(b) Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility

Who cannot join

(1) Active hepatitis B or active hepatitis C infection.
(2) Any active, uncontrolled infection.
(3) Class III/IV cardiovascular disability according to the New York Heart Association Classification.
(4) Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
(5) Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
(6) Active acute or chronic GVHD requiring systemic therapy.

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(7) Dependence on systemic steroids or immunosuppressant medications.
(8) Receipt of prior huCART19-IL18 therapy.
(9) CNS disease as defined by disease-cohort as follows:
(a) NHL/CLL Patients: Active CNS disease. Note: Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS involvement.
(b) ALL Patients: CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
(10) Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to their cancer or previous cancer treatment.
(11) Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
(12) Current antiretroviral therapy (ART) regimen includes a non-nucleoside reverse transcriptase inhibitor (NNRTI).
(13) History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
(14) Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abramson Cancer Center Clinical Trials Service contact

215-349-8245

PMCancerResearch@Pennmedicine.upenn.edu

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center Clinical Trials Service, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

Other trials in United States

About this study

Official title: Phase 1 Study of huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers

Read the detailed description

This is a phase 1, open-label study to assess the safety, feasibility, and preliminary efficacy of huCART19-IL18-CD428z cells in patients with HIV that have CD19 positive cancers. huCART19-IL18-CD428z cells are genetically modified autologous T cells engineered by co-transduction with two lentiviral vectors: a). huCART19-IL18 targeting the CD19+ B-cells and b). C34-CD4CAR_CD28 targeting HIV. This investigational product is primarily intended to treat the patient's CD19-positive cancer. However, by co-expressing CD19-targeting and HIV-specific CARs in the same T cell, we aim to use cancer cells to stimulate T-cell growth, which may also help HIV-specific CAR T cells multiply and survive longer in the body.

This study will be initiated as a single arm study (Treatment Arm A), which will evaluate a single fixed dose of huCART19-IL18-CD428z cells following lymphodepleting chemotherapy. In participants who have a complete response to the huCART19-IL18-CD428z cells, an optional analytical treatment interruption (ATI) may be performed to evaluate the effectiveness of the CAR T cells to delay or prevent viral rebound in the absence of antiretroviral therapy.

Conditions: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Richter's Transformation
Being tested: huCART19-IL18-CD428z cells
Medical subject headings: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

huCART19-IL18-CD428z cellsBiological
huCART19-IL18-CD428z cells are genetically modified autologous T cells engineered by co-transduction with two lentiviral vectors: a). huCART19-IL18 targeting the CD19+ B-cells and b). C34-CD4CAR_CD28 targeting HIV.

Study groups in NCT07891468
Study group	Role	What they receive
Arm A	Experimental	Single fixed dose of 7x10^6 huCART19-IL18-CD428z cells (Dose Level 1; DL1) Receives: Biological: huCART19-IL18-CD428z cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the safety of huCART19-IL18-CD428z cells
Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE V6.0
Measured: Up to 15 years post-infusion
Evaluate the safety of huCART19-IL18-CD428z cells
Occurrence of treatment-limiting toxicities (TLTs)
Measured: 28 days post-huCART19-IL18-CD428z infusion

Secondary outcomes (12)

Evaluate manufacturing feasibility
Occurrence of product release failures; occurrence of dose failures
Measured: 2 months following enrollment
Overall Response Rate (ORR) - NHL/CLL/RT participants
Proportion of subjects with CR or PR at Month 3 as compared to baseline
Measured: Month 3
Overall Response Rate (ORR) - ALL participants
Proportion of subjects with CR/CRi/CRh/CRMRD- at Day 28 as compared to baseline.
Measured: Day 28
Best Overall Response (BOR) - NHL/CLL/RT participants
Proportion of subjects with a best overall response of CR or PR recorded between Month 3 and the end of Primary Follow-Up, as compared to baseline.
Measured: Month 3 - end of Primary Follow-Up
Best Overall Response (BOR) - ALL participants
Proportion of subjects with a best overall response of CR/CRi/CRh/CRmrd- between Day 28 and Month 6, as compared to baseline.
Measured: Day 28 - Month 6
Duration of Response (DOR) - NHL/CLL/RT participants
Time from the date when the response criteria of CR/PR is first met (at or following Month 3), to the date of disease progression/relapse or death, whichever occurs first.
Measured: Up to 15 years post-huCART19-IL18-CD428z infusion
Duration of Response (DOR) - ALL participants
Time from the date when the response criteria of CR/CRi/CRh/CRmrd- is first met (at or following Day 28), to the date of disease progression/relapse or death, whichever occurs first.
Measured: Up to 15 years post-huCART19-IL18-CD428z infusion
Progression-free Survival (PFS) - NHL/CLL/RT participants
Duration of time from the huCART19-IL18-CD428z infusion to the date of confirmed disease progression or death, whichever occurs first.
Measured: Up to 15 years post-huCART19-IL18-CD428z infusion
Event-free Survival (EFS) - ALL participants
Duration of time from the initial huCART19-IL18-CD428z infusion to the earliest date of disease progression/relapse, receipt of new anticancer therapy (including huCART19-IL18-CD428z retreatment and/or HSCT, even if in the setting of ongoing CR), or death
Measured: Up to 15 years post-huCART19-IL18-CD428z infusion
Overall Survival (OS)
Duration of time from the first huCART19-IL18-CD428z infusion to the date of death
Measured: Up to 15 years post-huCART19-IL18-CD428z infusion
Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy
HIV viral rebound using Hologic's Aptima® HIV-1 Quant Dx Assay
Measured: Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed.
Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy
Duration of Analytical Treatment Interruption (ATI)
Measured: Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2027Dec 2042

First posted23 Oct 2026
Study startJan 2027 (estimated)
Primary completionDec 2042 (estimated)
Study completionDec 2042 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07891468
Sponsor's protocol ID: 28426 (26-8450)
Status last verified: Oct 2026
First submitted: 16 Oct 2026
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Abramson Cancer Center Clinical Trials Service

215-349-8245

PMCancerResearch@Pennmedicine.upenn.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Study of huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
ClinicalTrials.gov ID: NCT07891468
Acronym / sponsor ID: 28426 (26-8450)
Conditions: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Richter's Transformation
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 6 participants (estimated)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Jan 2027 (estimated)
Primary completion: Dec 2042 (estimated)
Study completion: Dec 2042 (estimated)
First posted: 23 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm A	Experimental	Biological: huCART19-IL18-CD428z cellsSingle fixed dose of 7x10^6 huCART19-IL18-CD428z cells (Dose Level 1; DL1)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (40 listed)

(1) Signed informed consent form.
(2) Male or female age ≥ 18 years.
(3) HIV-1 infection diagnosed in accordance with WHO and CDC guidelines.
(4) Patients with one of the following B-cell malignancies:
(a) Non-Hodgkin's Lymphoma (NHL)- including the following sub-types:

Key exclusion criteria (16 listed)

(1) Active hepatitis B or active hepatitis C infection.
(2) Any active, uncontrolled infection.
(3) Class III/IV cardiovascular disability according to the New York Heart Association Classification.
(4) Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
(5) Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
huCART19-IL18-CD428z cellshuCART19-IL18-CD428z cells are genetically modified autologous T cells engineered by co-transduction with two lentiviral vectors: a). huCART19-IL18 targeting the CD19+ B-cells and b). C34-CD4CAR_CD28 targeting HIV.	Biological	Arm A

Primary outcome

Evaluate the safety of huCART19-IL18-CD428z cells
Time frame: Up to 15 years post-infusion
Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE V6.0
Evaluate the safety of huCART19-IL18-CD428z cells
Time frame: 28 days post-huCART19-IL18-CD428z infusion
Occurrence of treatment-limiting toxicities (TLTs)

12 secondary outcomes

Evaluate manufacturing feasibility
Time frame: 2 months following enrollment
Overall Response Rate (ORR) - NHL/CLL/RT participants
Time frame: Month 3
Overall Response Rate (ORR) - ALL participants
Time frame: Day 28
Best Overall Response (BOR) - NHL/CLL/RT participants
Time frame: Month 3 - end of Primary Follow-Up
Best Overall Response (BOR) - ALL participants
Time frame: Day 28 - Month 6
Duration of Response (DOR) - NHL/CLL/RT participants
Time frame: Up to 15 years post-huCART19-IL18-CD428z infusion
Duration of Response (DOR) - ALL participants
Time frame: Up to 15 years post-huCART19-IL18-CD428z infusion
Progression-free Survival (PFS) - NHL/CLL/RT participants
Time frame: Up to 15 years post-huCART19-IL18-CD428z infusion
Event-free Survival (EFS) - ALL participants
Time frame: Up to 15 years post-huCART19-IL18-CD428z infusion
Overall Survival (OS)
Time frame: Up to 15 years post-huCART19-IL18-CD428z infusion
Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy
Time frame: Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed.
Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy
Time frame: Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Individual participant dataSharing planned: No

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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.

Abramson Cancer Center Clinical Trials Service contact

215-349-8245

PMCancerResearch@Pennmedicine.upenn.edu

Stefan Barta, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing huCART19-IL18-CD428z cells in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by University of Pennsylvania 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 40 inclusion and 16 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: opening soon, as of the sponsor's last update on 2 Nov 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abramson Cancer Center Clinical Trials Service (215-349-8245, PMCancerResearch@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of huCART19-IL18-CD428z cells (time frame: Up to 15 years post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07891468.

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 2 Nov 2026.