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New CAR-T therapy shows promise for Hard-to-Treat blood cancers

NCT ID NCT03960840

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment called rapcabtagene autoleucel, a type of CAR-T cell therapy, in adults with certain blood cancers like chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL). Some participants also receive the drug ibrutinib. The goal is to see if the treatment is safe and can shrink or control the cancer. About 217 people are taking part in this early-phase trial.

What this could mean

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

Active substance
rapcabtagene autoleucel (a CAR-T cell therapy) and ibrutinib (a targeted drug)
What this could lead to
If successful, this could offer a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants. The therapy may cause severe side effects, and it is not yet known if it will work better than existing treatments.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

217 people

The number who actually took part.

Started

Jun 2019

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 100 years

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: * ECOG performance status 0-1 for ALL and DLBCL * ECOG performance status 0-2 for 1L HR LBCL at screening * CLL or SLL diagnosis according to iwCLL criteria * CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy * DLBCL diagnosis by local histopathology * DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT) * Refractory or relapsed CD19-positive ALL * ALL with morphologic disease in the bone marrow 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis: * IPI score of 3, 4 or 5 * MYC and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma) * Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent) DA-EPOCH-R. * Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial. Exclusion Criteria: * Prior CD19-directed therapy * Prior administration of a genetically engineered cellular product * Prior allogeneic HSCT * Richter's transformation * For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS. * Active CNS lymphoma * For 1L HR LBCL: Active or prior history CNS involvement by malignancy * Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis Other protocol-defined inclusion/exclusion may apply.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma large B-cell lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia Chronic lymphocytic leukemia Diffuse large B-cell lymphoma Large B-cell lymphoma Small lymphocytic lymphoma

Contacts and locations

Locations

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Mass Gen Hosp Cancer Center

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Rennes, 35033, France

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37221, United States

  • St Davids South Austin Medical Ctr

    Austin, Texas, 78704, United States

  • Stanford University Medical Center

    Stanford, California, 94305-5826, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Pennsylvania Clinical

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.