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Non Hodgkin LymphomaPhase 1NCT05989204

TmCD19-IL18 in CD19+ Cancers

A Phase 1 study testing TmCD19-IL18 in people with Non Hodgkin Lymphoma, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
TmCD19-IL18
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
13 Nov 2023to 1 Oct 2041
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

None listed.

Who cannot join

  • Active hepatitis B, active hepatitis C, or other active, uncontrolled infection.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification.
  • Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
  • Active acute or chronic GVHD requiring systemic therapy.
  • Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications.
  • Receipt of prior huCART19-IL18 therapy.
Show all 11Show fewer
  • CNS disease as defined by disease-cohort as follows:
  • Cohort A: 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.
  • Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods.
  • 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.
  • Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase I Trial of TmCD19-IL18 CAR T Cells in Patients With Relapsed or Refractory CD19+ Cancers

This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.

Being tested
TmCD19-IL18
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • TmCD19-IL18Biological

    autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)

Study groups in NCT05989204
Study groupRoleWhat they receive
NHL Dose Level 1Experimental7x10^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
Receives: Biological: TmCD19-IL18
NHL Dose Level -1Experimental2x10^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
Receives: Biological: TmCD19-IL18
NHL Dose Level 2Experimental2x10^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
Receives: Biological: TmCD19-IL18
NHL Dose Level 3Experimental6x10^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
Receives: Biological: TmCD19-IL18
NHL Dose Level 1aExperimental5x10^6 TmCD19-IL18 CAR T cells
Receives: Biological: TmCD19-IL18

What is being measured

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

  1. Number of subjects with dose limiting toxicities (DLTs)

    Measured: 28 days after TmCD19-IL18 CART T cell infusion

  2. Determination of maximum tolerated dose (MTD)

    Measured: 28 days after TmCD19-IL18 CART T cell infusion

  3. Incidence of Adverse Events as assessed by CTCAE v5.0

    Measured: Up to 15 years

Secondary outcomes (8)

  1. Percentage of manufacturing products that meet release criteria

    Measured: 1 month

  2. Overall response rate (ORR)

    Measured: 4 months

  3. Best overall response (BOR)

    Measured: 12 months

  4. Duration of response (DOR)

    Measured: 15 years

  5. Overall Survival (OS)

    Measured: 15 years

  6. Progression Free Survival (PFS)

    Measured: 15 years

  7. Characterize low level disease and B cell assessment in response to TmCD19-IL18 CAR T cells

    Polychromatic flow cytometry-based assessment of lymphoma and B cells

    Measured: 15 years

  8. Characterize low level disease and B cell assessment in response to TmCD19-IL18 CAR T cells

    Presence or absence of malignant B cells by Next-Generation Immunoglobulin Heavy Chain Sequencing (NGIS)

    Measured: 15 years

Timeline

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

  1. First posted14 Aug 2023
  2. Study start13 Nov 2023
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2041 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
3+3 Dose escalation design
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989204
Sponsor's protocol ID
UPCC 12423
Status last verified
Jul 2026
First submitted
2 Aug 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TmCD19-IL18 in people with Non Hodgkin Lymphoma, 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 0 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 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?

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?

Number of subjects with dose limiting toxicities (DLTs) (time frame: 28 days after TmCD19-IL18 CART T cell infusion). The study lists 3 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 NCT05989204.

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 10 Jul 2026.

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