APRIL CAR-T cell therapy for relapsed multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of APRIL CAR-T cell therapy in patients with relapsed and/or refractory multiple myeloma who are positive for BCMA/TACI. It is a single-arm, open-label trial conducted at a single center, enrolling 36 patients. The primary focus is on assessing dose-related safety, with eligibility criteria including specific histological confirmations and health parameters. The study aims to provide a new treatment option for patients who have limited responses to existing therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM)：

   1. Patients with MM 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 leision which is hard to be eradicated 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\>2.5mg/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

Where it's running

• The First Affiliated Hospital，College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: He Huang, PhD
• Email: hehuangyu@126.com
• Phone: 86-13605714822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo BCMA-CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

  This study tests VV169, a one-time in vivo CAR-T treatment, in adults with multiple myeloma that has come back or not responded to standard therapy.

  Recruiting Phase 1 Vyriad, Inc. · Rochester, Minnesota · NCT07802717

• CAR-T therapy for relapsed or refractory multiple myeloma

  This study tests a CAR-T therapy in people with multiple myeloma whose disease has come back or not responded to treatment.

  Recruiting at 2 sites Phase 2 National Institute of Blood and Marrow Transplant (NIBMT), Pakistan · Rawalpindi, Punjab Province and 1 other locations · NCT07689058

• Off-the-shelf BCMA CAR‑T for relapsed or refractory multiple myeloma

  This trial will try a universal (allogeneic) BCMA-directed CAR‑T cell treatment for people with relapsed or refractory multiple myeloma to see if it is safe and can reduce disease.

  Recruiting Bioray Laboratories · Shanghai · NCT07248176

• NT-I7 added to BCMA CAR-T therapy for relapsed or refractory multiple myeloma

  This trial tests whether giving NT-I7 after BCMA CAR-T therapy helps boost T-cell expansion and possibly improve responses in people with relapsed or refractory multiple myeloma.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07200089

• Sequential CAR-T therapy targeting BCMA and GPRC5D for relapsed or refractory multiple myeloma

  This will try sequential CAR-T cell therapy against BCMA and GPRC5D in people with relapsed or refractory multiple myeloma to see if it is safe and helps control the disease.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT07032129

• Testing a new CAR T-cell therapy for patients with advanced B-cell cancers

  This study is testing a new CAR T-cell therapy to see if it can help adults with hard-to-treat B-cell cancers feel better and improve their health.

  Recruiting Phase 1 Technische Universität Dresden · Dresden · NCT05836896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.