Hematologic DiseasesPhase 1NCT07701889
Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
A Phase 1 study testing 20-19 Tan BB06oz CAR T in people with Hematologic Diseases, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- 20-19 Tan BB06oz CAR T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for leukapheresis, patients must have an aggressive CD19+ B cell malignancy with relapsed or refractory disease, defined as below.
- To be eligible for treatment with 20-19 Tan BB06z CAR-T cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR-T cell infusion, regardless of therapy administered following leukapheresis.
- To be included in this study, participants must meet the following criteria:
- 1. Patients with R/R B-Cell malignancies (see below) which commonly express CD19 and CD20. Eligible disease subtypes include the following:
- o DLBCL/HGBL de novo or DLBCL/HGBL transformed from an indolent lymphoma, refractory to front-line chemoimmunotherapy containing an anthracycline and CD20-directed therapy (without achievement of CR).
- Relapsed or refractory DLBCL/HGBL following 2 or more prior chemoimmunotherapy regimens containing an anthracycline and CD20-directed therapy following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma.
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- Relapse following a single prior chemoimmunotherapy regimen containing an anthracycline and CD20-directed therapy following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma and considered ineligible for high dose chemotherapy and autologous stem cell rescue as determined by the investigator.
- Mantle Cell Lymphoma after 2 lines of therapy. Patients must have previously received chemoimmunotherapy and a prior BTK inhibitor.
- Secondary CNS Lymphoma after 2 lines of therapy, 1 of which must include an autologous stem cell transplant or deemed ineligible by the investigator.
- Patients with B cell acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML) in lymphoid blast crisis.
- Patients with Philadelphia chromosome-negative B cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy.
- Patients with Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor.
- Burkitt lymphoma refractory to at least 1 line of multi-agent chemotherapy or relapsed following 1 or more lines of multi-agent chemotherapy.
- Patients must have at least one FDG-avid (PET-avid) measurable lesion.
- For B-cell ALL and/or CML in lymphoid blast crisis, presence of > 20% lymphoid blasts in the blood or bone marrow, or extramedullary infiltration with FDG-avid (PET-avid) measurable lesion is required.
- 3. Prior CD19-targeted therapies, including CAR-T cell therapy, do not exclude participation. However, CD19 and CD20 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment for patients who have received such therapies.
- Have the following clinical laboratory values:
- Adequate renal function defined as;
- Adult participants:
- Creatinine Clearance >30 mL/min (Cockroft-Gault equation)
- Pediatric participants: Use age/gender -appropriate creatinine as follows: Age Maximum Plasma Creatinine (mg/dL) Male Female 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4
- ≥ 16 years 1.7 1.4
- Direct bilirubin ≤2.0 mg/dL
- AST and ALT ≤3.0x upper limit of normal (ULN)
- Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
- ECOG performance status 0-1 for adult participants ≥18 years of age. Pediatrics - Lansky/Karnofsky score ≥70: use Karnofsky for participants ≥16 years of age and Lansky for participants <16 years of age (see Appendix A).
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Participants of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
- 9. Participant, or legal representative, must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Pregnant or lactating patients.
- Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan during screening.
- Patients with active known autoimmune disease requiring systemic T cell suppressive therapy are ineligible.
- Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T cell suppressive therapy are ineligible.
- Patients with following cardiac conditions will be excluded:
- New York Heart Association (NYHA) stage III or IV congestive heart failure
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- Myocardial infarction ≤6 months prior to enrollment
- Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- Patients with HIV are ineligible.
- Patients with active hepatitis B infection (as manifest by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen) are ineligible.
- Patients with active hepatitis C infection (as manifest by detectable hepatitis C virus RNA by PCR) are ineligible. Patients with detectable antibodies to hepatitis C virus will be screened by PCR for evidence of active infection.
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
- Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
- Unwilling or unable to follow protocol requirements.
- Any other condition/issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
Official title: A Phase I Trial of Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies
Read the detailed description
The purpose of this study is to test the safety of 20-19 Tan BB06z CAR T cells in people with different types of relapsed/refractory CD19-positive blood cancer. Different doses of 20-19 Tan BB06z CAR T cells will be tested to find the highest dose that causes few or mild side effects in participants
- Conditions
- Hematologic Diseases
- Being tested
- 20-19 Tan BB06oz CAR T
- Keywords
- hematologic malignanices
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-19 Tan BB06oz CAR TBiological
This investigational product is a genetically modified chimeric antigen receptor t-cell product expressing a biospecific anti CD19/CD20 and incorporating both 4-1BB and mutated CD28 costimulatory domains.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Dose Escalation | Experimental | Dose escalation will determine maximum tolerated dose Receives: Biological: 20-19 Tan BB06oz CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MDT)
MTD will be established from Dose limiting toxicities after infusion
Measured: up to 2 years
Secondary outcomes (3)
Event Free Survival
Time from Car-T cell infusion to disease progression, relapse or death from anycause,w hichever occured first. EFS will be assessed by using the Kaplan-Meier method.
Measured: UP to 2 years
Overall Survival
Date of infusion until death. OS will be assessed using the Kaplan-Meier method
Measured: Up to 2 years
persistence of modified T-cells
Duration of T-cell persistence will be estimated using flow cytometry in peripheral blood and bone marrow.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Niu, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701889
- Sponsor's protocol ID
- I-3832925
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07701889
- Acronym / sponsor ID
- I-3832925
- Conditions
- Hematologic Diseases
- Keywords
- hematologic malignanices
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 14 Jul 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.
To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies
Detailed description
The purpose of this study is to test the safety of 20-19 Tan BB06z CAR T cells in people with different types of relapsed/refractory CD19-positive blood cancer. Different doses of 20-19 Tan BB06z CAR T cells will be tested to find the highest dose that causes few or mild side effects in participants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Dose Escalation | Experimental | Biological: 20-19 Tan BB06oz CAR TDose escalation will determine maximum tolerated dose |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- To be eligible for leukapheresis, patients must have an aggressive CD19+ B cell malignancy with relapsed or refractory disease, defined as below.
- To be eligible for treatment with 20-19 Tan BB06z CAR-T cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR-T cell infusion, regardless of therapy administered following leukapheresis.
- 1. Patients with R/R B-Cell malignancies (see below) which commonly express CD19 and CD20. Eligible disease subtypes include the following:
- o DLBCL/HGBL de novo or DLBCL/HGBL transformed from an indolent lymphoma, refractory to front-line chemoimmunotherapy containing an anthracycline and CD20-directed therapy (without achievement of CR).
- Relapsed or refractory DLBCL/HGBL following 2 or more prior chemoimmunotherapy regimens containing an anthracycline and CD20-directed therapy following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma.
Key exclusion criteria (16 listed)
- Pregnant or lactating patients.
- Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan during screening.
- Patients with active known autoimmune disease requiring systemic T cell suppressive therapy are ineligible.
- Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T cell suppressive therapy are ineligible.
- Patients with following cardiac conditions will be excluded:
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 |
|---|---|---|
| 20-19 Tan BB06oz CAR TThis investigational product is a genetically modified chimeric antigen receptor t-cell product expressing a biospecific anti CD19/CD20 and incorporating both 4-1BB and mutated CD28 costimulatory domains. | Biological | Arm 1 - Dose Escalation |
Primary outcome
Maximum Tolerated Dose (MDT)
Time frame: up to 2 years
MTD will be established from Dose limiting toxicities after infusion
3 secondary outcomes
Event Free Survival
Time frame: UP to 2 years
Overall Survival
Time frame: Up to 2 years
persistence of modified T-cells
Time frame: Up to 2 years
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 15 Jul 2026.
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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.
Alex Niu, MD principal investigator
Roswell Park Comprehensive Cancer Center
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 20-19 Tan BB06oz CAR T in people with Hematologic Diseases, run by Roswell Park Cancer Institute 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 28 inclusion and 16 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 15 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?
Maximum Tolerated Dose (MDT) (time frame: up to 2 years). 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 15 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.