Clinical trial on CAR-T Cell therapy for patients with BCMA/TACI-positive relapsed and/or refractory multiple myeloma

Clinical trials in cancer
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Share This Post

Brief Summary:

A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma

 

Detailed Description:

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selection of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. The primary objective is to explore safety; the main consideration is dose-related safety.

 

Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM):
    1. Patients with MM who relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression;
    2. Relapsed after hematopoietic stem cell transplantation;
    3. Cases with recurrent positive minimal residual disease;
    4. Extramedullary lesion, which is hard to eradicate by chemotherapy or radiotherapy.
  2. Male or female aged 18–75 years;
  3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  6. Estimated survival time ≥ 3 months;
  7. ECOG performance status 0 to 2;
  8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
  8. Creatinine > 2.5 mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin > 2.0 mg/dl;
  9. Other uncontrolled diseases that were not suitable for this trial;
  10. Patients with HIV infection;
  11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

PiggyBac Transposon System
AI & Technology

PiggyBac Transposon System: A Revolutionary Tool in Cancer Gene Therapy

The PiggyBac Transposon System is revolutionizing genetic engineering in cancer research, especially in CAR T-cell therapy. With its high integration efficiency and large cargo capacity, it provides a powerful, non-viral alternative to traditional gene delivery methods. Learn how PiggyBac is advancing personalized cancer treatment and shaping the future of oncology.

Breakthrough 2025 Treatments for Advanced Breast Cancer
Biotech Innovations

Breakthrough Treatments for Advanced Breast Cancer in 2025

In 2025, advanced breast cancer treatment has entered a new era. Precision medicine and targeted therapies are enabling doctors to tailor care based on genetic profiles. Immunotherapy and antibody-drug conjugates are delivering more effective tumor targeting, while experimental cellular treatments like CAR T-cell therapy show immense promise. These cutting-edge options are transforming outcomes and quality of life for patients facing metastatic breast cancer. Explore the latest innovations driving hope and progress.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

We Are Online! Chat With Us!
Scan the code