APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2027-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Yake Biotechnology Ltd.

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