Not yet taking people in United StatesPhase 1

Engineered immune cells for blood cancers in people living with HIV

Tests huCART19-IL18-CD428z cells in adults with HIV and certain lymphomas or leukemias.

Key facts

Who runs it: University of Pennsylvania
Where: Philadelphia, United StatesSee the site
Trial code: NCT07891468
Registry title: huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Status: Not yet recruiting
Phase: Phase 1
People taking part: 6 people, planned
Starts: Jan 2027
Expected to end: Dec 2042
Type of study: Interventional
Treatments tested: huCART19-IL18-CD428z cells
Record updated: 2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV who have a relapsed or hard-to-treat B-cell cancer that carries the CD19 marker. It tests an experimental cell therapy.

Age: 18 years or older
Sex: All sexes can join.
Disease stage: A B-cell cancer that came back or did not respond to treatment: non-Hodgkin lymphoma, chronic lymphocytic leukemia, Richter's transformation or acute lymphoblastic leukemia. Most need at least 2 earlier lines of treatment. Active disease within 12 weeks. ECOG performance status of 0 or 1.
Earlier treatment: At least 2 earlier lines of treatment for most lymphomas and CLL; CLL also needs an earlier BTK inhibitor and venetoclax unless they are not safe or not tolerated. Richter's transformation: at least 1 earlier line or no response to first treatment. No earlier huCART19-IL18 therapy. Stable antiretroviral therapy (ART) with no changes in the last 28 days.
Biomarker or test result: CD19 on the cancer cells, shown by a lab test. HIV viral load of 30 copies/mL or lower within 30 days before eligibility is confirmed.

Main reasons for not taking part

Active hepatitis B or hepatitis C infection
Any active infection that is not under control
Antiretroviral therapy that includes a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Active graft-versus-host disease needing treatment, or dependence on steroids or immune-suppressing drugs
Pregnant or breastfeeding

This trial only enrols participants living with HIV. The registry sentence this rests on: (3) HIV-1 infection diagnosed in accordance with WHO and CDC guidelines.

The registry criteria, word for word

Show all 56 criteriaShow less

Who can take part

(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:
(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 take part

(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
(7) Dependence on systemic steroids or immunosuppressant medications
(8) Receipt of prior huCART19-IL18 therapy
(12) Current antiretroviral therapy (ART) regimen includes a non-nucleoside reverse transcriptase inhibitor (NNRTI)
(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
(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
(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

Where in United States

University of PennsylvaniaPhiladelphia, United StatesContact: Abramson Cancer Center Clinical Trials ServiceNot yet recruiting

About the trial

What the trial wants to find out

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).

The group in the trial

Arm ATreatment being tested
Single fixed dose of 7x10\^6 huCART19-IL18-CD428z cells (Dose Level 1; DL1)
Treatment: huCART19-IL18-CD428z cells

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record

ClinicalTrials.gov NCT07891468

Listed on ClinicalTrials.gov.

Official title

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

Plain-language title

Engineered immune cells for blood cancers in people living with HIVGenerated from the registry record. The registry title is the official one.

AI summary

From the trial's eligibility criteria. Read by machine on 12 November 2026.

Record updated

2 November 2026