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RecruitingLast updated: 7 February 2024

This phase I trial evaluates the safety and effectiveness of engineered CAR-T cells (CD19 targeted) alone for treatment of patients with diffuse large B-cell lymphoma and in combination with targeted therapy (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphomaPhase I, Open Label, Multicenter, Dose Escalation Study of CD19-specific CAR-T Cells in Adult Patients With CLL/SLL and DLBCL

Clinical summary

Summary

Patients eligible for this trial will receive a single infusion of engineered CAR-T cells and daily doses of ibrutinib for treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma, or a single infusion of engineered CAR-T cells for treatment of diffuse large B-cell lymphoma.

Please note, PCCTU is currently recruiting to the Acute Lymphoblastic Leukaemia (ALL) arm only.

Conditions

This trial is treating patients with chronic lymphocytic leukaemia, small lymphocytic lymphoma and diffuse large B-cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

Phase I, Open Label, Multicenter, Dose Escalation Study of CD19-specific CAR-T Cells in Adult Patients With CLL/SLL and DLBCL

Eligibility

Inclusion

  • ECOG performance status 0-1
  • 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/THL)
  • 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 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

  • 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 CNS involvement by malignancy
  • Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis

Other protocol-defined inclusion/exclusion may apply.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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