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出境医 / 临床实验 / BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma
BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma
Study Description
Brief Summary:
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Biological: Anti-BCMA CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide Drug: Immune inhibitors | Early Phase 1 |
Detailed Description:
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma |
| Estimated Study Start Date : | July 2019 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | May 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: anti-BCMA CAR-T
Administration of anti-BCMA CAR-T cells to patients with multiple myeloma
|
Biological: Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Drug: Fludarabine 30mg/m2/d
Drug: Cyclophosphamide 300mg/m2/d
|
|
Experimental: anti-BCMA CAR-T+ Immune inhibitors
Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma
|
Biological: Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Drug: Fludarabine 30mg/m2/d
Drug: Cyclophosphamide 300mg/m2/d
Drug: Immune inhibitors Immune inhibitors
|
Outcome Measures
Primary Outcome Measures :
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 [ Time Frame: 6 months ]Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Secondary Outcome Measures :
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm [ Time Frame: 8 weeks ]Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
- Duration of CAR-positive T cells in circulation [ Time Frame: 6 months ]Duration of CAR-positive T cells in circulation
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Expected survival > 12 weeks
- Diagnosis of Multiple Myeloma by MWG criteria 20
- Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
- Important organs function enough to tolerate this therapy
- At least 90 days after stem cell transplantation
- Accessible to intravenous injection, and no white blood cell collection contraindications
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
- Able to understand and sign the Informed Consent Document.
Exclusion Criteria:
- Patients with symptoms of central nervous system
- Patients with second malignancies in addition to multiple myeloma
- Active hepatitis B or C, HIV infections
- Any other active diseases could affect the enrollment of this trial
- Suffering severe cardiovascular or respiratory disease
- Poorly controlled hypertension
- Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
- A history of mental illness and poorly controlled
- Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
- Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
- Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Active systemic infections or uncontrolled infection within 14 days prior enrollment
- Subjects suffering disease affects the understanding of informed consent or complying with study protocol.
Contacts and Locations
Contacts
| Contact: Hongliang Fang | 021-58552006 | fanghongliang@dashengbio.com | |
| Contact: Weijun Fu | 021-81885423 | fuweijun2010@hotmail.com |
Locations
| China, Shanghai | |
| Shanghai Changzheng Hospital | |
| Shanghai, Shanghai, China, 200003 | |
Sponsors and Collaborators
Hrain Biotechnology Co., Ltd.
Shanghai Changzheng Hospital
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||||||
| First Posted Date ICMJE | May 9, 2019 | ||||||||
| Last Update Posted Date | June 24, 2019 | ||||||||
| Estimated Study Start Date ICMJE | July 2019 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 [ Time Frame: 6 months ] Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma | ||||||||
| Official Title ICMJE | A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma | ||||||||
| Brief Summary | The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma. | ||||||||
| Detailed Description | Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Early Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Myeloma | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
10 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2022 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03943472 | ||||||||
| Other Study ID Numbers ICMJE | anti-BCMA CART | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hrain Biotechnology Co., Ltd. | ||||||||
| Study Sponsor ICMJE | Hrain Biotechnology Co., Ltd. | ||||||||
| Collaborators ICMJE | Shanghai Changzheng Hospital | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Hrain Biotechnology Co., Ltd. | ||||||||
| Verification Date | May 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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