In short
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.
Key points
- Clinical trials are studying AUTOLOGOUS T-CELLS TRANSDUCED WITH LENTIVIRAL VECTOR ENCODING AN ANTI-SLAMF7 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR in multiple myeloma. The available study is a Phase 1/2 trial with 33 participants and is authorised. Researchers are mainly checking feasibility, safety, and antitumor activity. In Phase I, the study looks at side effects and the highest dose that can be used for Phase IIa. In Phase IIa, it also measures how many patients have a partial response or better after treatment. The trial focuses on patients with multiple myeloma.
Clinical trial overview
The available study is a first-in-human clinical study of genetically modified T-cells in people with multiple myeloma. 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.
Who the trials are for
The target population in the trial data is patients with multiple myeloma. No other patient groups are listed in the source data.
Trial phase and study design
This study is a Phase 1/2 interventional trial with an enrollment of 33 participants. 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. Phase IIa then continues to assess safety and early signs of benefit.
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). The study also aims to identify the MTD of SLAMF7 CAR-T that can be used in Phase IIa.
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. These response checks are planned at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24 after infusion. The brief summary also says the study is evaluating efficacy, defined as the overall response rate (ORR).
Trial status and enrollment
The trial is listed as Authorised. The planned enrollment is 33 people.
Key points for patients
- This research is focused on one cancer type: multiple myeloma.
- The study is early stage, so it is mainly checking safety and whether the treatment can be given as planned.
- Researchers are also looking for early signs that the treatment may help the cancer respond.
- The study includes safety problems that are important in cell therapy, such as cytokine release syndrome and neurotoxicity.