B-cell Non Hodgkin LymphomaPhase 1NCT05094206
CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies
A Phase 1 study testing 0.75x10^6 cells/kg CAR20.19.22 cells, 1x10^6 cells/kg CAR20.19.22 cells and 2.5x10^6 cells/kg CAR20.19.22 cells in people with B-cell Non Hodgkin Lymphoma and B-cell Chronic Lymphocytic Leukemia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
In this phase I study, the investigators will first evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma, B-cell Chronic Lymphocytic Leukemia
- What is being tested?
- 0.75x10^6 cells/kg CAR20.19.22 cells, 1x10^6 cells/kg CAR20.19.22 cells and 2.5x10^6 cells/kg CAR20.19.22 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 29 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Positive beta-human chorionic gonadotropin (HCG) 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 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.
- Refusal to participate in the long-term follow-up protocol.
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- Patients with active CNS involvement by malignancy on MRI or by lumbar puncture.
- 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.
- Anti-CD20 directed treatment within 4 weeks of cell infusion.
- Anti-CD19 directed treatment within 4 weeks of cell infusion.
- Anti-CD22 directed treatment within 4 weeks of cell infusion.
- Cytotoxic chemotherapy, oral chemotherapeutic agents or antibody directed treatment within 14 days of lymphodepletion.
- Radiation is allowed to a single symptomatic site as long as other sites of measurable disease are present on eligibility scan.
- If patients receive steroids or any systemic disease targeting treatment, repeat scans are needed to confirm disease burden pre-lymphodepletion.
- Cytotoxic chemotherapy, oral chemotherapeutic agents or antibody directed treatment within 14 days of apheresis.
- Corticosteroids are allowable up until 7 days prior to apheresis.
- 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.
- Prior CAR T-cell therapy (autologous or allogeneic) unless >90 days from prior CAR with repeat biopsy post-CAR demonstrating CD19 or CD20 expression of ≥20%.
- Special Criteria for 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. Lactating women are eligible for this study but will be asked to not provide breast milk to their child from Day -4 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.
- 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.
United States1 site
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Phase I Trial of Anti-CD20, Anti-CD19, Anti-CD22 CAR (CAR20.19.22) T-cells for Relapsed, Refractory B-cell Malignancies
In this phase I study, the investigators will first evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL).
Read the detailed description
This is a phase I, interventional, open label, dose-finding treatment study designed to evaluate the safety and efficacy CAR20.19.22 T-cells in adult patients with B-cell malignancies that have failed prior therapies.
- Being tested
- 0.75x10^6 cells/kg CAR20.19.22 cells, 1x10^6 cells/kg CAR20.19.22 cells, 2.5x10^6 cells/kg CAR20.19.22 cells, 5x10^6 cells/kg CAR20.19.22 cells, Dose expansion: The maximum tolerated dose of CAR20.19.22 cells
- Keywords
- B-cell antigens, B-cell Non Hodgkin Lymphoma, B-cell Chronic Lymphocytic Leukemia, CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75x10^6 cells/kg CAR20.19.22 cellsBiological
Dose escalation: CAR20.19.22 cells will be administered at one of three dose levels either fresh or thawed after cryopreservation by IV injection.
Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6.
1x10^6 cells/kg CAR20.19.22 cellsBiological
CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection.
Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6.
2.5x10^6 cells/kg CAR20.19.22 cellsBiological
CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection.
The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6.
5x10^6 cells/kg CAR20.19.22 cellsBiological
CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection.
The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6.
Dose expansion: The maximum tolerated dose of CAR20.19.22 cellsBiological
Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 0.75x10^6 cells/kg CAR20.19.22 cells |
| Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 1x10^6 cells/kg CAR20.19.22 cells |
| Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 2.5x10^6 cells/kg CAR20.19.22 cells |
| Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 5x10^6 cells/kg CAR20.19.22 cells |
| Indolent B-cell NHL Dose Expansion: CAR20.19.22 | Experimental | The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg. Receives: Biological: Dose expansion: The maximum tolerated dose of CAR20.19.22 cells |
| Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 0.75x10^6 cells/kg CAR20.19.22 cells |
| Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 1x10^6 cells/kg CAR20.19.22 cells |
| Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 2.5x10^6 cells/kg CAR20.19.22 cells |
| Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22 | Experimental | The investigators will start at a dose of 1.0x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. Receives: Biological: 5x10^6 cells/kg CAR20.19.22 cells |
| Aggressive B-cell NHL Dose Expansion: CAR20.19.22 | Experimental | The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg. Receives: Biological: Dose expansion: The maximum tolerated dose of CAR20.19.22 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Non-hematologic Adverse Events after Infusion
Occurrence of adverse events will be defined as non-hematologic Grade 3/4 toxicity grade per NCI CTCAE version 5.0.
Measured: 28 days after infusion
Number of grade 3-4 cytokine release syndrome (CRS).
Grade 3-4 CRS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Measured: 28 days after infusion
Number of grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS)
Grade 3-4 ICANS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Measured: 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.
- First posted26 Oct 2021
- Study start30 Jun 2022
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Why it stopped: Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- 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
- NCT05094206
- Sponsor's protocol ID
- PRO00041528
- Status last verified
- Sep 2024
- First submitted
- 17 Oct 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Anti-CD20, Anti-CD19, Anti-CD22 CAR (CAR20.19.22) T-cells for Relapsed, Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT05094206
- Acronym / sponsor ID
- PRO00041528
- Keywords
- B-cell antigens, B-cell Non Hodgkin Lymphoma, B-cell Chronic Lymphocytic Leukemia, CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 26 Oct 2021 (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.
In this phase I study, the investigators will first evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL).
Detailed description
This is a phase I, interventional, open label, dose-finding treatment study designed to evaluate the safety and efficacy CAR20.19.22 T-cells in adult patients with B-cell malignancies that have failed prior therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 0.75x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 1x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 2.5x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 5x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Indolent B-cell NHL Dose Expansion: CAR20.19.22 | Experimental | Biological: Dose expansion: The maximum tolerated dose of CAR20.19.22 cellsThe maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg. |
| Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 0.75x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 1x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 2.5x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22 | Experimental | Biological: 5x10^6 cells/kg CAR20.19.22 cellsThe investigators will start at a dose of 1.0x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities. |
| Aggressive B-cell NHL Dose Expansion: CAR20.19.22 | Experimental | Biological: Dose expansion: The maximum tolerated dose of CAR20.19.22 cellsThe maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- Positive beta-human chorionic gonadotropin (HCG) 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 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.
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 |
|---|---|---|
| 0.75x10^6 cells/kg CAR20.19.22 cellsDose escalation: CAR20.19.22 cells will be administered at one of three dose levels either fresh or thawed after cryopreservation by IV injection. Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6. | Biological | Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22, Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22 |
| 1x10^6 cells/kg CAR20.19.22 cellsCAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6. | Biological | Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22, Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22 |
| 2.5x10^6 cells/kg CAR20.19.22 cellsCAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6. | Biological | Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22, Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22 |
| 5x10^6 cells/kg CAR20.19.22 cellsCAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6. | Biological | Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22, Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22 |
| Dose expansion: The maximum tolerated dose of CAR20.19.22 cellsDose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg. | Biological | Aggressive B-cell NHL Dose Expansion: CAR20.19.22, Indolent B-cell NHL Dose Expansion: CAR20.19.22 |
Primary outcome
Number of Non-hematologic Adverse Events after Infusion
Time frame: 28 days after infusion
Occurrence of adverse events will be defined as non-hematologic Grade 3/4 toxicity grade per NCI CTCAE version 5.0.
Number of grade 3-4 cytokine release syndrome (CRS).
Time frame: 28 days after infusion
Grade 3-4 CRS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Number of grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: 28 days after infusion
Grade 3-4 ICANS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Results and safety
The study was stopped early (reason given: Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
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 0.75x10^6 cells/kg CAR20.19.22 cells, 1x10^6 cells/kg CAR20.19.22 cells and 2.5x10^6 cells/kg CAR20.19.22 cells in people with B-cell Non Hodgkin Lymphoma and B-cell Chronic Lymphocytic Leukemia, 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 29 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
The study was stopped early (reason given: Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.). Results are not available in the source record.
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 Non-hematologic Adverse Events after Infusion (time frame: 28 days after 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?
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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.