Multiple Myeloma in Relapse Clinical Trial
Official title:
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
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
Status | Recruiting |
Enrollment | 36 |
Est. completion date | August 20, 2027 |
Est. primary completion date | August 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital,College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University | Yake Biotechnology Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after APRIL targeted CAR T-cells infusion | |
Primary | Incidence of treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events [Safety and Tolerability] | Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion | |
Secondary | Multiple Myeloma (MM), Overall response rate (ORR) | Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 1, 3, 6, 12, 18 and 24 | At Month 1, 3, 6, 12, 18 and 24 | |
Secondary | MM, Overall survival (OS) | From the first infusion of APRIL CAR-T cells to death or the last visit | Up to 2 years after APRIL CAR-T cells infusion | |
Secondary | MM, Event-free survival (EFS) | From the first infusion of APRIL CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit | Up to 2 years after APRIL CAR-T cells infusion | |
Secondary | Quality of life including sports activity | Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12 | At Baseline, Month 1, 3, 6, 9 and 12 | |
Secondary | Activities of Daily Living (ADL) score | Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12 | At Baseline, Month 1, 3, 6, 9 and 12 | |
Secondary | Instrumental Activities of Daily Living (IADL) score | Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12 | At Baseline, Month 1, 3, 6, 9 and 12 | |
Secondary | Hospital Anxiety and Depression Scale (HADS) score | Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12 | At Baseline, Month 1, 3, 6, 9 and 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01435720 -
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04094961 -
Ixazomib + Pomalidomide + Dexamethasone In MM
|
Phase 1/Phase 2 | |
Recruiting |
NCT06068400 -
Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Multiple Myeloma
|
N/A | |
Recruiting |
NCT03601624 -
Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
|
Phase 2 | |
Recruiting |
NCT05020444 -
TriPRIL CAR T Cells in Multiple Myeloma
|
Phase 1 | |
Not yet recruiting |
NCT03706547 -
Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
|
Phase 1 | |
Active, not recruiting |
NCT02970747 -
Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone or in Combination With Darzalex® and Dexamethasone in Multiple Myeloma Patients
|
||
Not yet recruiting |
NCT06411301 -
A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors
|
Phase 1 | |
Completed |
NCT01965353 -
A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma
|
Phase 1 | |
Not yet recruiting |
NCT05581875 -
A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory
|
Phase 1/Phase 2 | |
Terminated |
NCT03687125 -
Tinostamustine Conditioning and Autologous Stem Cell
|
Phase 1/Phase 2 | |
Recruiting |
NCT06282978 -
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
|
Phase 2 | |
Recruiting |
NCT06158412 -
All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma
|
Phase 2 | |
Active, not recruiting |
NCT03030261 -
Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT04925193 -
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT05121103 -
A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma
|
Phase 1 | |
Recruiting |
NCT04603872 -
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
|
Early Phase 1 | |
Terminated |
NCT05191472 -
Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies
|
Phase 2 | |
Completed |
NCT03136653 -
A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04162353 -
BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma
|
Phase 1 |