Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

Launched by SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called CAR-T cell therapy for patients with multiple myeloma or plasmacytoma, both of which are types of blood cancer. The goal is to find out how safe and effective this therapy is, especially for patients who are considered high-risk. Researchers also want to understand how long these specially modified CAR-T cells can stay in the body and how well they work against cancer cells. The study is currently recruiting participants aged between 18 and 75 who have been diagnosed with multiple myeloma or plasmacytoma and are willing to commit to follow-up appointments.

To be eligible for this trial, participants must be in a complete remission and have a good chance of survival for at least 12 weeks. They should also have had a prior stem cell transplant and be able to provide informed consent. However, pregnant or breastfeeding women, those with uncontrolled infections, or certain medical conditions will not be able to participate. If you join this trial, you can expect to receive the CAR-T cell therapy and be monitored closely for any side effects and how your body responds to the treatment. This research aims to improve treatment options for people facing these challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects with multiple myeloma or plasmacytoma
• • Strictly complete remission (sCR) is a treatment goal
• • Expected survival \> 12 weeks
• • After prior auto-SCT is eligible regardless of other prior therapies
• • Adequate venous access for apheresis, and no other contraindications for leukapheresis
• • Voluntary informed consent is given and commitment to continued follow-up
• Exclusion Criteria:
• • Pregnant or lactating women
• • Uncontrolled active infection
• • Active HIV, hepatitis B or hepatitis C infection
• • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
• • Any medical conditions that may preclude participation