NCT04657861 APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
| NCT ID | NCT04657861 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Multiple Myeloma in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-05-03 |
| Primary Completion | 2024-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2022-05-03 with a primary completion date of 2024-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04657861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04657861 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04657861 currently recruiting?
Yes, NCT04657861 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT04657861 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04657861 clinical trial?
NCT04657861 is sponsored by Zhejiang University. The trial plans to enroll 36 participants.