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Evaluating rapcabtagene autoleucel for various blood cancers

Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

Phase1; Phase2 Interventional Novartis · NCT03960840

This study is testing a new CAR-T therapy called rapcabtagene autoleucel to see if it can safely help people with different types of blood cancers like CLL, DLBCL, ALL, and high-risk LBCL.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsibrutinib, chemotherapy
Locations44 sites (Los Angeles, California and 43 other locations)
Trial IDNCT03960840 on ClinicalTrials.gov

What this trial studies

This clinical trial is a phase I/II open-label, multi-center study assessing the safety and preliminary efficacy of rapcabtagene autoleucel, a CAR-T therapy, in patients with chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute lymphoblastic leukemia (ALL), and high-risk large B-cell lymphoma (LBCL). The study includes a combination treatment with ibrutinib for CLL/SLL and single-agent treatments for DLBCL and ALL. The trial is structured into two phases, with the first phase focusing on dose escalation and feasibility, while the second phase aims to further evaluate the treatment's effectiveness in specific patient cohorts.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory CLL, DLBCL, ALL, or newly diagnosed high-risk LBCL who meet specific eligibility criteria.

Not a fit: Patients who have not received prior treatment or those with certain contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory blood cancers.

How similar studies have performed: Other studies utilizing CAR-T therapies have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaDiffuse Large B-cell LymphomaAcute Lymphoblastic LeukemiaLarge B-cell LymphomaCAR-TIbrutinibCLL
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.