Status:
UNKNOWN
Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
CARsgen Therapeutics Co., Ltd.
Conditions:
Refractory or Relapsed Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
Detailed Description
This study is designed to determine the safety, tolerability and engraftment potential of anti-BCMA lentivirus-transduced autologous T cells in patients with refractory or relapsed multiple myeloma. ...
Eligibility Criteria
Inclusion
- Patients aged between 18 \~ 70 with relapsed or refractory multiple myeloma.
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
- Patients with relapsed or refractory multiple myeloma who meet the following conditions:
- 1\) Curative efficacy is little or disease progressed after 2 courses of standard treatment regimen;
- 2\) Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen;
- 3\) More than 60 days between last treatment and disease progression;
- 4\) Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT;
- 5\) Disease progression is defined as per "Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revision in 2015)". At least one of the following conditions should be met:
- \- i. Serum M-protein increases ≥ 25% (absolute increase should be ≥ 5 g/L). If serum M protein is ≥ 50 g/L at baseline, increase of serum M protein can be ≥ 10 g/L;
- \- ii. Urine M-protein increases ≥ 25% (absolute increase should be ≥ 200 mg/24 h);
- \- iii. If the serum and urine M-protein are not detectable, a ≥ 25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be ≥ 100 mg/L);
- \- iv. Bone marrow plasma cell percentage increases ≥ 25% (absolute increase should be ≥ 10%);
- \- v. Size of existing bone lesions or soft tissue plasmacytomas increases by ≥ 25%, or development of new lytic bone lesions or soft tissue plasmacytomas;
- \- vi. Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is \> 2.8 mmol/L or 11.5 mg/dL);
- \- vii. Disease progression must be confirmed by 2 sequential assessments.
- Expected survival \> 12 weeks.
- Disease is measurable, and at least one of the following conditions should be satisfied:
- 1\) Serum M-protein is ≥ 10 g/L;
- 2\) 24-hour urine M-protein is ≥ 200 mg;
- 3\) Serum FLC is ≥ 5 mg/dL;
- 4\) Plasmacytomas that can be measured or evaluated by imaging;
- 5\) Bone marrow plasma cell percentage is ≥ 20%.
- ECOG scores 0 - 1.
- Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis.
- WBC ≥ 1.5×10\^9/L, PLT ≥ 45×10\^9/L;
- Serum creatinine ≤ 1.5 ULN.
- ALT ≤ 2.5 ULN, AST ≤ 2.5 ULN. The above lab results should not include those obtained from continuous supportive treatment that is ongoing.
Exclusion
- Patients with any of the following conditions are not eligible for this study.
- Transduction of target lymphocytes \< 10%, expansion in response to αCD3/CD28 costimulation \< 5-fold.
- Pregnant or lactating women.
- HIV positive, or HCV positive
- Uncontrolled active infection, including active tuberculosis and HBV DNA copies ≥ 1×10\^3 copies/mL.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Allergic to immunotherapies and related drugs.
- Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
- Hyponatremia: serum sodium level \< 125 mmol/L.
- Baseline serum potassium \< 3.5 mmol/L (taking potassium supplements before participating in the study to raise potassium level is acceptable).
- Previous treatment with chemoradiotherapy, immunotherapy and tumor-targeting drug conducted 2 weeks prior to participation in this study or blood collection.
- Patients have undertaken immunosuppressor for graft-versus-host disease (GVHD) within 4 weeks before participation in this study or blood collection, or the patient is diagnosed with acute or chronic GVHD.
- Other severe disease that may restrain patients from participating in this study (e.g. diabetes, severe cardiac dysfunction, myocardial infarction or unstable arrhythmias or unstable angina in recent 6 months, gastric ulcer, active autoimmune disease, etc.).
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03380039
Start Date
October 13 2017
End Date
July 2 2023
Last Update
October 12 2020
Active Locations (1)
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1
Xin Hua Hospital of Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, China, 200092