HSP-CAR19M

Clinical trials are studying HSP-CAR19M in adults with certain B-cell non-Hodgkin lymphomas. These studies aim to assess safety, toxicity, and possible benefit of the treatment. The main target groups are people with relapsed or refractory large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma.

Table of contents

Trial overview

The available trial is an interventional study, which means people receive a treatment that is being tested.[1] It is studying HSP-CAR19M in adults with B-cell non-Hodgkin lymphoma.[1]

The study is authorised and plans to enroll 40 participants.[1]

Who the study is for

The trial is for adults with relapsed/refractory large B-cell non-Hodgkin lymphoma, mantle cell lymphoma, and follicular lymphoma.[1] Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[1]

These conditions are all types of B-cell non-Hodgkin lymphoma, which are cancers that start in B cells, a kind of white blood cell.[1]

Study phase and design

This is a Phase 1/2 trial.[1] Phase 1/2 studies first look closely at safety, then also look for early signs that the treatment may help.[1]

The brief summary says the study is evaluating the safety, toxicity, and efficacy of autologous memory T cells that are expanded outside the body and genetically modified with a chimeric antigen receptor targeting CD19.[1] In simple terms, the trial is testing a personalized cell therapy made from the patient’s own cells.[1]

What the trial measures

The primary outcome is safety associated with infusion of HSP-CAR19M cells.[1] Safety outcomes help researchers see whether the treatment can be given without causing unacceptable problems.[1]

In the expansion phase, the study also evaluates safety and efficacy of HSP-CAR19M cell administration.[1] Efficacy means how well the treatment works against the cancer.[1]

Treatments used in the study

The intervention list includes HSP-CAR19M and several other drugs given by intravenous infusion.[1] The trial data do not explain the full role of each listed drug, so the key point is that HSP-CAR19M is part of a treatment plan studied in this trial.[1]

Intravenous infusion means a treatment is given through a vein, usually over time.[1]

What the trial details mean for patients

For patients, this study is an early-stage attempt to learn whether HSP-CAR19M can be used safely in hard-to-treat B-cell lymphomas.[1] The trial is not just looking at one disease, but at several related lymphoma types in adults.[1]

Because the study is Phase 1/2 and has a small planned enrollment, it is mainly designed to gather early information rather than provide final proof of benefit.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519790-19-00 Phase 1/2 Relapsed/refractory large B-cell non-Hodgkin lymphoma, mantle cell lymphoma, and follicular lymphoma Authorised 40

Ongoing Clinical Trials on HSP-CAR19M

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Glossary

  • B-cell non-Hodgkin lymphoma: A group of cancers that start in B cells, which are a type of white blood cell.
  • Relapsed: A disease that comes back after it had improved.
  • Refractory: A disease that does not respond well to treatment.
  • Large B-cell lymphoma: A fast-growing type of B-cell non-Hodgkin lymphoma.
  • Mantle cell lymphoma: A type of B-cell non-Hodgkin lymphoma that starts in the mantle zone of lymph nodes.
  • Follicular lymphoma: A type of B-cell non-Hodgkin lymphoma that often grows more slowly.
  • Phase 1/2: An early clinical trial phase that first checks safety and then looks at early signs of benefit.
  • Interventional study: A study where participants receive a treatment or procedure being tested.
  • Primary outcome: The main result the researchers want to measure.
  • Efficacy: How well a treatment works.
  • Infusion: A treatment given slowly into a vein.

References

  1. https://clinicaltrials.gov/study/2024-519790-19-00