B-cell Non Hodgkin LymphomaPhase 1NCT07335328
Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
A Phase 1 study testing 1 X 10^6 cells/kg, 2.5 X 10^6 cells/kg and Dose expansion: The maximum tolerated dose of CAR-T cells in people with B-cell Non Hodgkin Lymphoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma
- What is being tested?
- 1 X 10^6 cells/kg, 2.5 X 10^6 cells/kg and Dose expansion: The maximum tolerated dose of CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 May 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing 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 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 unless believed to be due to underlying disease.
- Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. A minimum of 14 days or 5 half-lives of the drug, whichever is shorter, of washout is required prior to apheresis.
- Patients with active CNS involvement by malignancy on MRI or by lumbar puncture:
Show all 24Show fewer
- Patients with prior CNS disease that have been effectively treated will be eligible, provided 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.
- 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 the lymphodepletion start date.
- 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 be restarted 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/FL/MZL is allowable in patients with transformed large cell lymphoma).
- Refusal to participate in the long-term follow-up protocol.
- 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 the 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 a 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
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Nirav Shah, MD, 414-805-4600, nishah@mcw.edu
Nirav Shah, MD
About this study
Official title: Phase 1 Study of a Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
Read the detailed description
The purpose of this study is to determine the safety of fully human lentiviral 20.19 (h20.19) CAR T cells in patients with relapsed, refractory B-cell malignancies. A maximum of 12 patients will be treated in the Phase 1 cohort followed by a 12-patient expansion cohort (approximately 21 to 24 patients total).
- Conditions
- B-cell Non Hodgkin Lymphoma
- Being tested
- 1 X 10^6 cells/kg, 2.5 X 10^6 cells/kg, Dose expansion: The maximum tolerated dose of CAR-T cells
- Keywords
- CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 X 10^6 cells/kgBiological
Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
2.5 X 10^6 cells/kgBiological
Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
Dose expansion: The maximum tolerated dose of CAR-T cellsBiological
Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10^6 cells/kg or 2.5 X 10^6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 0: 1 X 10^6 cells/kg | Experimental | The investigators will start at a dose of 1 X 10^6 cells/kg and escalate based on the presence of toxicities. Receives: Biological: 1 X 10^6 cells/kg |
| Dose Level 1: 2.5 X 10^6 cells/kg | Experimental | The investigators will start at a dose of 1 X 10^6 cells/kg and escalate based on the presence of toxicities. Receives: Biological: 2.5 X 10^6 cells/kg |
| Dose Expansion: Maximum Tolerated Dose | Experimental | The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10^6 cells/kg or 2.5 X 10^6 cells/kg. After completing the dose escalation cohort, the investigators will open a 12-patient dose-expansion evaluation of h20.19 CAR T cells. Receives: Biological: Dose expansion: The maximum tolerated dose of CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The maximum tolerated dose (MTD) is the highest dose of a drug or treatment that does not cause dose-limiting toxicities (DLTs). This trial will utilize a 3+3 design to determine the safe dose. Three patients are enrolled and treated at the starting (lowest) dose level.
- 0 DLTs: If none of the three patients experience a DLT, the next cohort of three patients is treated at the next higher dose level.
- 1 DLT: If one patient experiences a DLT, an additional three patients are enrolled at the same dose level (expanding the cohort to six patients total).
- 2 or more DLTs: If two or more patients in a cohort of three (or two or more in an expanded cohort of six) experience DLTs, the MTD is considered to have been exceeded. The trial stops escalating and the previous dose level is defined as the MTD.
Measured: 28 days post CAR-T cell infusion
Secondary outcomes (7)
Adverse Events
The number of subjects with adverse events, defined as non-hematologic Grade 3/4 events per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, as well as Grade 3-4 CRS, ICANS, and IEC-HS events per the recent ASTCT consensus criteria, that are possibly, probably, or definitely related to study treatment and do not resolve to ≤ Grade 2 by Day 28 post-infusion.
Measured: Up to 2 Years post CAR-T cell infusion
Overall Response Rate (ORR)
ORR is defined as the number of subjects who achieve a best overall response of complete response (CR) or partial response (PR), as determined by the Lugano (for Non-Hodgkin Lymphoma subjects) or Hallek (for Chronic Lymphocytic Leukemia subjects) criteria, following h20.19 CAR T-cell infusion.
Measured: 28 days post CAR-T cell infusion
Complete Response (CR) Rate
CR rate is defined as the number of subjects who achieve a CR following h20.19 CAR T-cell infusion.
Measured: 28 days post CAR-T cell infusion
Duration of Response (DOR)
DOR is defined as the time from the first documented CR or partial response (PR) following h20.19 CAR T-cell infusion to disease progression, as determined by the Lugano or Hallek criteria, or death, whichever occurs first.
Measured: Up to 2 years post CAR-T cell infusion
Relapse rate
Relapse rate is defined as the number of subjects who experience relapse among those who achieve a best overall response rate of CR or PR following h20.19 CAR T-cell infusion.
Measured: 120 days; 1 year; 2 year post CAR-T cell infusion
Overall Survival (OS)
OS is defined as the time from h20.19 CAR T-cell infusion to documented death.
Measured: 120 days; 1 year; 2 year post CAR-T cell infusion
Progression-free Survival (PFS)
PFS is defined as the time from h20.19 CAR T-cell infusion to documented disease progression or death, whichever occurs first.
Measured: 120 days; 1 year; 2 year post CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav Shah, Medical College of Wisconsin
- Investigators
- Nirav Shah, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335328
- Sponsor's protocol ID
- PRO00059183
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of a Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
- ClinicalTrials.gov ID
- NCT07335328
- Acronym / sponsor ID
- PRO00059183
- Conditions
- B-cell Non Hodgkin Lymphoma
- Keywords
- CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 13 Jan 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.
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
Detailed description
The purpose of this study is to determine the safety of fully human lentiviral 20.19 (h20.19) CAR T cells in patients with relapsed, refractory B-cell malignancies. A maximum of 12 patients will be treated in the Phase 1 cohort followed by a 12-patient expansion cohort (approximately 21 to 24 patients total).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 0: 1 X 10^6 cells/kg | Experimental | Biological: 1 X 10^6 cells/kgThe investigators will start at a dose of 1 X 10^6 cells/kg and escalate based on the presence of toxicities. |
| Dose Level 1: 2.5 X 10^6 cells/kg | Experimental | Biological: 2.5 X 10^6 cells/kgThe investigators will start at a dose of 1 X 10^6 cells/kg and escalate based on the presence of toxicities. |
| Dose Expansion: Maximum Tolerated Dose | Experimental | Biological: Dose expansion: The maximum tolerated dose of CAR-T cellsThe maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10^6 cells/kg or 2.5 X 10^6 cells/kg. After completing the dose escalation cohort, the investigators will open a 12-patient dose-expansion evaluation of h20.19 CAR T cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing 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 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 unless believed to be due to underlying disease.
- Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. A minimum of 14 days or 5 half-lives of the drug, whichever is shorter, of washout is required prior to apheresis.
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 |
|---|---|---|
| 1 X 10^6 cells/kgDose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection. | Biological | Dose Level 0: 1 X 10^6 cells/kg |
| 2.5 X 10^6 cells/kgDose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection. | Biological | Dose Level 1: 2.5 X 10^6 cells/kg |
| Dose expansion: The maximum tolerated dose of CAR-T cellsDose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10^6 cells/kg or 2.5 X 10^6 cells/kg. | Biological | Dose Expansion: Maximum Tolerated Dose |
Primary outcome
Maximum tolerated dose
Time frame: 28 days post CAR-T cell infusion
The maximum tolerated dose (MTD) is the highest dose of a drug or treatment that does not cause dose-limiting toxicities (DLTs). This trial will utilize a 3+3 design to determine the safe dose. Three patients are enrolled and treated at the starting (lowest) dose level. * 0 DLTs: If none of the three patients experience a DLT, the next cohort of three patients is treated at the next higher dose level. * 1 DLT: If one patient experiences a DLT, an additional three patients are enrolled at the same dose level (expanding the cohort to six patients total). * 2 or more DLTs: If two or more patients in a cohort of three (or two or more in an expanded cohort of six) experience DLTs, the MTD is considered to have been exceeded. The trial stops escalating and the previous dose level is defined as the MTD.
7 secondary outcomes
Adverse Events
Time frame: Up to 2 Years post CAR-T cell infusion
Overall Response Rate (ORR)
Time frame: 28 days post CAR-T cell infusion
Complete Response (CR) Rate
Time frame: 28 days post CAR-T cell infusion
Duration of Response (DOR)
Time frame: Up to 2 years post CAR-T cell infusion
Relapse rate
Time frame: 120 days; 1 year; 2 year post CAR-T cell infusion
Overall Survival (OS)
Time frame: 120 days; 1 year; 2 year post CAR-T cell infusion
Progression-free Survival (PFS)
Time frame: 120 days; 1 year; 2 year post CAR-T cell infusion
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 7 Oct 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.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Nirav Shah, MD principal investigator
Medical College of Wisconsin
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 1 X 10^6 cells/kg, 2.5 X 10^6 cells/kg and Dose expansion: The maximum tolerated dose of CAR-T cells in people with B-cell Non Hodgkin Lymphoma, 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 24 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 7 Oct 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 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?
Maximum tolerated dose (time frame: 28 days post CAR-T cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.