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

NCT07701889 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: I-3832925
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hematologic Diseases

Keywords

hematologic malignanices

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MDT)

  MTD will be established from Dose limiting toxicities after infusion

  up to 2 years

Secondary Outcomes (3)

• Event Free Survival

  UP to 2 years

• Overall Survival

  Up to 2 years

• persistence of modified T-cells

  Up to 2 years

Study Arms (1)

Arm 1 - Dose Escalation

EXPERIMENTAL

Dose escalation will determine maximum tolerated dose

Biological: 20-19 Tan BB06oz CAR T

Interventions

20-19 Tan BB06oz CAR T BIOLOGICAL

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.

Arm 1 - Dose Escalation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Alex Niu, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)