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AUTOLOGOUS T-CELLS TRANSDUCED WITH LENTIVIRAL VECTOR ENCODING AN ANTI-SLAMF7 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR

Clinical trials are studying AUTOLOGOUS T-CELLS TRANSDUCED WITH LENTIVIRAL VECTOR ENCODING AN ANTI-SLAMF7 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR in people with multiple myeloma. These studies are looking at feasibility, safety, and antitumor activity, as well as how many patients have a response to treatment. The main target population is patients with multiple myeloma.

Table of Contents

Clinical trial overview

The available study is a first-in-human clinical study of genetically modified T-cells in people with multiple myeloma.[1] The study is testing AUTOLOGOUS T-CELLS TRANSDUCED WITH LENTIVIRAL VECTOR ENCODING AN ANTI-SLAMF7 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR to assess feasibility, safety, and antitumor activity.[1]

Who the trials are for

The target population in the trial data is patients with multiple myeloma.[1] No other patient groups are listed in the source data.[1]

Trial phase and study design

This study is a Phase 1/2 interventional trial with an enrollment of 33 participants.[1] Phase I is focused on safety and on finding the maximum tolerated dose, which means the highest dose that can be given without unacceptable side effects.[1] Phase IIa then continues to assess safety and early signs of benefit.[1]

What the researchers measure

The main Phase I outcomes are the type, frequency, and severity of adverse events, including serious adverse events, cytokine release syndrome, and neurotoxicity (also called ICANS).[1] The study also aims to identify the MTD of SLAMF7 CAR-T that can be used in Phase IIa.[1]

In Phase IIa, the researchers again measure safety and also check how many patients reach partial response or better using the IMWG Uniform Response Criteria for Multiple Myeloma.[1] These response checks are planned at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24 after infusion.[1] The brief summary also says the study is evaluating efficacy, defined as the overall response rate (ORR).[1]

Trial status and enrollment

The trial is listed as Authorised.[1] The planned enrollment is 33 people.[1]

Key points for patients

  • This research is focused on one cancer type: multiple myeloma.[1]

  • The study is early stage, so it is mainly checking safety and whether the treatment can be given as planned.[1]

  • Researchers are also looking for early signs that the treatment may help the cancer respond.[1]

  • The study includes safety problems that are important in cell therapy, such as cytokine release syndrome and neurotoxicity.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04499339 Phase 1/2 Multiple myeloma Authorised 33

FAQ

  • What condition is being studied in these trials? The trials are studying multiple myeloma. This is the only condition listed in the trial data.
  • What is the main goal of the studies? The studies aim to check feasibility, safety, and antitumor activity. They also measure how many patients have a partial response or better.
  • Who can take part in these trials? The target population is patients with multiple myeloma. The trial data does not list more detailed entry rules.
  • What phase are these trials in? The study is in Phase 1/2. Phase I focuses on safety and dose finding, and Phase IIa looks more at safety and response.
  • What results are the researchers measuring? They measure side effects such as serious adverse events, cytokine release syndrome, and neurotoxicity. They also measure partial response or better over time after infusion.

Ongoing Clinical Trials on AUTOLOGOUS T-CELLS TRANSDUCED WITH LENTIVIRAL VECTOR ENCODING AN ANTI-SLAMF7 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR

  • Study on the Safety and Effectiveness of SLAMF7 CAR-T Cells for Patients with Multiple Myeloma

    Not recruiting

    1 1
    Investigated drugs:
    Germany

Glossary

  • Multiple myeloma: A cancer of plasma cells, which are a type of white blood cell found in the bone marrow.
  • Feasibility: Whether a treatment approach can be done in real patients as planned.
  • Safety: How well a treatment is tolerated and what side effects it may cause.
  • Antitumor activity: Signs that a treatment may help fight or shrink cancer.
  • Phase I: The first part of a clinical trial, usually focused on safety and dose finding.
  • Phase IIa: An early part of Phase II that looks more closely at safety and early signs of benefit.
  • Adverse event: A health problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event: A major health problem, such as one that is life-threatening or needs hospital care.
  • Cytokine release syndrome: A strong immune reaction that can happen after some cell therapies.
  • Neurotoxicity: Nervous system problems that may affect the brain, nerves, or thinking.
  • ICANS: Immune effector cell-associated neurotoxicity syndrome, a type of nerve or brain side effect seen with some immune cell treatments.
  • Partial response: A decrease in signs of cancer, but not a complete disappearance.

References