AzTrials
AzTrials

Non Hodgkin Lymphoma (NHL)Phase 1/2NCT04186520

CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

A Phase 1/2 study testing 8/12-Day Production of Car-T Cells, 8/12-Day Production of Cryopreserved Car-T Cells and 12-Day Production of Car-T Cells in people with Non Hodgkin Lymphoma (NHL) and Mantle Cell Lymphoma (MCL), run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
8/12-Day Production of Car-T Cells, 8/12-Day Production of Cryopreserved Car-T Cells and 12-Day Production of Car-T Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
18 May 2020to 28 Feb 2029
Phase
Phase 1/2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
  • Positive beta- human chorionic gonadotropin (HCG) in female of childbearing potential.
  • Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
  • History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily.
  • Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
  • Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.
Show all 28Show fewer
  • Refusal to participate in the long-term follow-up protocol
  • Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)
  • Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.
  • Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.
  • Prior allogeneic CAR T-cell therapy
  • Previous recipients of autologous CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are <100 days post prior CAR-T cell treatment (does not include re-enrollment) or have >5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec)
  • Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry
  • Anti-CD20 antibody treatment within 4 weeks of cell infusion
  • Anti-CD19 antibody treatment within 4 weeks of cell infusion
  • Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion
  • Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells
  • Oral chemotherapeutic agents or antibody directed treatment within 7 days of apheresis
  • BTK inhibitors are allowed until 1-day prior to apheresis and can re-start until 1-day prior to lymphodepletion
  • Patients post solid organ transplant who develop high grade lymphomas or leukemias
  • Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia/follicular lymphoma (FL)/marginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma)
  • SPECIAL CRITERIA REGARDING FERTILITY AND CONTRACEPTION
  • Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure [hysterectomy or bilateral oophorectomy]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.
  • Acceptable birth control includes a combination of two of the following methods:
  • Condoms (male or female) with or without a spermicidal agent.
  • Diaphragm or cervical cap with spermicide
  • Intrauterine device (IUD)
  • Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy tubal ligation, salpingectomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception

Trial locations and contacts

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

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States1 site, 1 recruiting

  • Medical College of Wisconsin and Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Nirav Shah, MD, nishah@mcw.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Read the detailed description

This is a Phase 1/Phase 2 study. The objectives are as follows:

  1. Phase 1: Determine the safety of a fixed dose of 2.5x10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15 in relapsed refractory B-cell NHL with flexible 8/12-day manufacturing and a fixed 12-day manufacturing process along with an evaluation in chronic lymphocytic leukemia (CLL) and central nervous system (CNS) lymphoma.
  2. Phase 1b: Four arms: Arm A: 8/12 flexible manufacturing arm. Determine safety, efficacy, and feasibility of flexible manufacturing. Arm B: Fixed 12-day manufacturing arm. Determine safety and efficacy of fixed CAR manufacturing. Arm C: 8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. Determine the impact of cryopreservation on safety or efficacy of LV20.19 CAR T-cells. Arm D: 8/12 flexible manufacturing expansion cohort in CLL. Determine safety and efficacy in CLL. Arm E: 8/12 flexible manufacturing cohort in central nervous system (CNS) lymphoma.
  3. Phase 2
  4. Determine the 3-month CR rate of CAR-20/19-T cells in MCL
  5. Determine the feasibility of a flexible manufacturing process of CAR-20/19-T cells from patient apheresis products using the CliniMACS Prodigy Cell processing device
Being tested
8/12-Day Production of Car-T Cells, 8/12-Day Production of Cryopreserved Car-T Cells, 12-Day Production of Car-T Cells
Keywords
CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy, B-cell Malignancies
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • 8/12-Day Production of Car-T CellsBiological

    A fixed dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

  • 8/12-Day Production of Cryopreserved Car-T CellsBiological

    A fixed cryopreserved dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

  • 12-Day Production of Car-T CellsBiological

    A fixed dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

Study groups in NCT04186520
Study groupRoleWhat they receive
8/12 Day Production of CAR-T for NHLExperimentalPhase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at eight or 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.
Receives: Biological: 8/12-Day Production of Car-T Cells
8/12 Day Production of CAR-T for CLLExperimentalPhase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with CLL. Patients will be enrolled in 3+3 fashion. Phase 1b: The enrollment will cap at 24 subjects.
Receives: Biological: 8/12-Day Production of Car-T Cells
8/12 Flexible Manufacturing with Mandated CryopreservationExperimental8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. The enrollment will cap at 24 subjects.
Receives: Biological: 8/12-Day Production of Cryopreserved Car-T Cells
12-Day Production of Car-T Cells for NHLExperimentalPhase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.
Receives: Biological: 12-Day Production of Car-T Cells
8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS LymphomaExperimentalPhase 1: Determine safety of 2.5x106 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with primary/secondary central nervous system (CNS) lymphoma. Phase 1b: Safety and efficacy will be evaluated in this study that will enroll 12 to 24 patients.
Receives: Biological: 8/12-Day Production of Car-T Cells
Phase 2 - Efficacy of CAR-20/19-T cells in MCLExperimentalSingle-stage Phase II design with three-month CR as the target endpoint.
Receives: Biological: 8/12-Day Production of Car-T Cells

What is being measured

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

  1. Number of Adverse Events after CAR 20/19-T cell infusion

    Incidence of adverse events using NCI CTCAE version 5.0.

    Measured: Within the first 28 days after infusion

Timeline

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

  1. First posted4 Dec 2019
  2. Study start18 May 2020
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04186520
Sponsor's protocol ID
PRO00037171
Status last verified
Feb 2026
First submitted
2 Dec 2019
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah V, Womack JA, Palen K, Johnson BD, Hematti P, Kearl TJ, Shah NN, Terhune SS, Dash RK. Data-driven computational modeling of CAR-T cell function. Front Immunol. 2026 May 13;17:1707783. doi: 10.3389/fimmu.2026.1707783. eCollection 2026.

    PubMed 42212152

  • Shah NN, Colina AS, Johnson BD, Szabo A, Furqan F, Kearl T, Schneider D, Vargas-Cortes M, Schmeling JL, Dwinell MB, Palen K, Longo W, Hematti P, Zamora AE, Hari P, Bucklan D, Cunningham A, Hamadani M, Fenske TS. Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma. J Clin Oncol. 2025 Jul 10;43(20):2285-2295. doi: 10.1200/JCO-24-02158. Epub 2025 Mar 31.

    PubMed 40163793

  • Zurko JC, Xu H, Chaney K, Schneider D, Szabo A, Hari P, Johnson BD, Shah NN. Bispecific targeting of CD20 and CD19 increases polyfunctionality of chimeric antigen receptor T-cell products in B-cell malignancies. Cytotherapy. 2022 Aug;24(8):767-773. doi: 10.1016/j.jcyt.2022.03.011. Epub 2022 May 18.

    PubMed 35597752

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 8/12-Day Production of Car-T Cells, 8/12-Day Production of Cryopreserved Car-T Cells and 12-Day Production of Car-T Cells in people with Non Hodgkin Lymphoma (NHL) and Mantle Cell Lymphoma (MCL), run by Medical College of Wisconsin 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 28 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: looking for participants now, as of the sponsor's last update on 23 Feb 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events after CAR 20/19-T cell infusion (time frame: Within the first 28 days after infusion). 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 NCT04186520, which also lists 3 linked publications.

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 23 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in