Double-Pronged immune cells take aim at stubborn blood cancers

NCT ID NCT07701889

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This phase 1 trial tests an experimental therapy called 20-19 Tan BB06z CAR-T for people with certain blood cancers (like lymphoma or leukemia) that have come back or not responded to treatment. The therapy involves taking a patient's own immune T cells, genetically modifying them in a lab to recognize and attack cancer cells carrying both CD19 and CD20 proteins, and then infusing them back. The main goal is to find the safest dose and understand side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a genetically modified immune cell called 20-19 Tan BB06z CAR-T that targets both CD19 and CD20 proteins on cancer cells
What this could lead to
If successful, this could lead to a more effective CAR-T cell therapy for blood cancers that are hard to treat, potentially reducing the chance of cancer cells escaping treatment.
What could go wrong
This is an early phase 1 trial with only 21 participants, so the main goal is safety, not effectiveness. There are risks of severe side effects like cytokine release syndrome and neurological problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

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