Bispecific CD19/CD20 CAR T-cell therapy for blood cancers
This study is testing a new type of cell therapy called 20-19 Tan BB06z CAR T cells. These cells are specially designed to target two markers (CD19 and CD20) found on certain blood cancer cells. The main goal is to find out how safe this treatment is and what dose causes the fewest side effects in people with blood cancers that have come back or not responded to other treatments (relapsed or refractory CD19+ hematologic malignancies). You might be able to join if you have an aggressive CD19+ B cell malignancy that has relapsed or is refractory, and you still have signs of cancer. The study plans to enroll 21 participants.
- Study design
- This is an interventional study that plans to enroll 21 participants. The phase is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose will be measured for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07701889
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
Not Yet Recruiting
PHASE1Ages 12+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~21 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:20-19 Tan BB06oz CAR T
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MDT)
Measured over up to 2 years
Conditions
NCT07701889
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Roswell Park Comprehensive Cancer Center
Buffalo, New Yorkno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alex Niu, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Comprehensive Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
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.
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.
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.
Have the following clinical laboratory values:
Adequate renal function defined as;
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.
Exclusion
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
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.
What this trial measures
- Maximum Tolerated Dose (MDT)up to 2 years
MTD will be established from Dose limiting toxicities after infusion