APRIL CAR-T cell therapy for relapsed multiple myeloma patients

Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

This study is testing a new CAR-T cell therapy for patients with relapsed multiple myeloma to see if it is safe and effective for those who haven't responded well to other treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04657861 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with BCMA/TACI positive relapsed or refractory multiple myeloma.

Not a fit: Patients with active infections or those who do not meet the health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment avenue for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promise with CAR-T cell therapies for multiple myeloma, indicating potential for success in this novel approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: He Huang, PhD

Conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Multiple Myeloma, CAR T-cell therapy, BCMA/TACI positive