A Phase 1b Clinical Trial of CRISPR Delivered Anti-BCMA Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of participants with treatment-emergent adverse events
研究概览
简要总结
This phase Ib trial tests the safety, side effects and best dose of clustered regularly interspaced short palindromic repeats (CRISPR) delivered anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells (1XX BCMA CAR-T cells) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Anti-BCMA CAR-T cell therapy is a type of treatment in which a person's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as BCMA, on the patient's cancer cells is added to the T cells in the laboratory by a tool called clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9. The special receptor is called a CAR. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy before CAR-T cells may decrease the number of lymphocytes (a type of white blood cells) in the blood and may help the 1XX BCMA CAR-T cells fight the cancer cells. Treatment with 1XX BCMA CAR-T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma (RRMM).
详细描述
PRIMARY OBJECTIVES:
Dose Escalation:
I. To evaluate the safety and toxicity of administering Chimeric Antigen Receptor T Cells (CAR-T) cells targeting BCMA to participants with Relapsed or Refractory Multiple Myeloma (RRMM).
II. To determine the maximum tolerated dose (MTD) for anti-BCMA CAR-T cells.
Dose Expansion:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign informed consent form.
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Diagnosis of multiple myeloma (per IMWG criteria) with relapsed or refractory disease and has received at least 3 prior lines of therapy including proteasome inhibitor immunomodulatory therapy, and anti-Cluster of differentiation 38 (CD38) antibody therapy.
- •Participants may have received BCMA targeted therapy and must be at least 6 months from last BCMA therapy.
- •Participants must have documented evidence of progressive disease within 12 months of the last line of therapy or be refractory/nonresponsive to their most recent line.
- •Participants must have measurable disease, defined as at least one of the criteria below:
- •Serum M-protein greater or equal to 0.5 grams per deciliter (g/dL).
- •Urine M-protein greater or equal to 200 milligrams, over a 24-hour period (mg/24 h).
- •Serum free light chain (FLC) assay: involved FLC level of ≥ 100 milligrams per liter (mg/L).
- •Adequate organ function, defined as:
- •Adequate bone marrow function for apheresis and lymphodepleting chemotherapy.
- •Hgb >8 gm/dl (transfusions allowed).
- •Platelets >50,000/microliter (uL) (in the absence of platelet transfusion within 7 days of apheresis, but transfusion permitted prior to lymphodepleting chemotherapy).
- •Absolute neutrophil count (ANC) > 1000/uL in the absence of growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days of apheresis, but growth factor permitted prior to lymphodepleting chemotherapy). For those patients who have evidence of duffy null, ANC >750/uL is allowed.
- •Absolute lymphocyte count (ALC) >300/uL.
- •Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 3 x institutional upper limit of normal (ULN) and Total bilirubin < 1.5 milligrams per deciliter (mg/dl) x institutional ULN, except with Gilbert's syndrome.
- •Serum creatinine clearance (CrCl) ≥ 30 milliliter per minute (mL/min) using Cockcroft-Gault formula or as measured with a 24 hour urine collection.
- •Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) > 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) and adequate pulmonary function (measured by room air pulse oximetry ≥ 92%).
- •Women of childbearing potential must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-BCMA CAR-T cells.
- •Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 6 months after CAR-T therapy.
排除标准
- •Autologous transplant within 12 weeks of planned CAR-T cell infusion.
- •Prior antitumor therapy as follows, prior to apheresis:
- •Investigational therapy within 14 days, or at least 5 half-lives.
- •Monoclonal antibody therapy within 21 days.
- •Cytotoxic therapy within 14 days.
- •Proteasome inhibitor therapy within 14 days.
- •Immunomodulatory therapy within 14 days.
- •Radiotherapy within 14 days - with the exception that if radiotherapy (XRT) covers <5% of marrow reserve - no rest window needed.
- •Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia, peripheral neuropathy and baseline hematologic toxicity that otherwise meets inclusion.
- •Active CNS multiple myeloma, plasma cell leukemia, primary AL amyloidosis or POEMS syndrome.
- •Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast). Any fully treated malignancies or indolent, clinically insignificant malignancies can be discussed among the study team to determine eligibility.
- •HIV seropositivity.
- •Serologic status reflects active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded).
- •Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
- •NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test.
- •Participants with currently symptomatic central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease OR seizure or stroke within 6 months.
- •History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
研究组 & 干预措施
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Leukapheresis (Procedure)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Chimeric Antigen Receptor T cells (CAR-T) Targeting BCMA (Biological)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Quality of Life (QoL) Questionnaires (Behavioral)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Bone Marrow Biopsy (Procedure)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Cyclophosphamide (Drug)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Biospecimen Collection (Biological)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Radiographic imaging (Procedure)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Leukapheresis (Procedure)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Chimeric Antigen Receptor T cells (CAR-T) Targeting BCMA (Biological)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Quality of Life (QoL) Questionnaires (Behavioral)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Bone Marrow Biopsy (Procedure)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Biospecimen Collection (Biological)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Radiographic imaging (Procedure)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Leukapheresis (Procedure)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Chimeric Antigen Receptor T cells (CAR-T) Targeting BCMA (Biological)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Quality of Life (QoL) Questionnaires (Behavioral)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Bone Marrow Biopsy (Procedure)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Biospecimen Collection (Biological)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Radiographic imaging (Procedure)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Fludarabine (Drug)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Fludarabine (Drug)
Expansion: MTD of Anti-BCMA CAR-T
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive the MTD of BCMA CAR-T cells/ infusion established in the dose escalation phase over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Cyclophosphamide (Drug)
Dose Escalation Starting Dose: 10 × 10^6 CAR + T cells/ infusion
Participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 10 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Fludarabine (Drug)
Dose Escalation: Planned Dose: 30 × 10^6 CAR + T cells/ infusion
Dependent on the safety profile of the starting dose, participants undergo leukapheresis and then receive lymphodepleting chemotherapy with fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days -5, -4, and -3. Participants also receive 30 × 10^6 BCMA CAR-T cells/ infusion over 5-30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo PET/CT or MRI at screening and urine and blood sample collection, bone marrow biopsy or aspiration throughout the study.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Proportion of participants with treatment-emergent adverse events
时间窗: Up to 12 months following CAR-T infusion
Proportion of participants with treatment-emergent adverse events of CAR-T in RRMM as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0), revised Cytokine Release Syndrome (CRS) grading criteria (for CRS grading), and the American Society for Transplantation and Cell Transplantation (ASTCT) Immune effector cell-associated neurotoxicity syndrome (ICANS) Consensus Grading for Adults (for neurotoxicity grading).
Proportion of participants who experience dose-limiting toxicity (DLT) (Dose Escalation)
时间窗: Up to 30 days
The DLT evaluable analysis set includes all participants in the dose-finding part of the study who have received the target doses of anti-BCMA CAR-T cell product, and who have either experienced a DLT or were followed for the full DLT evaluation period. The trial observation period for dose limiting toxicities will conclude at day 30 (approximately 4 weeks after CAR-T cell infusion)
Maximum Tolerated Dose (MTD) (Dose Escalation)
时间窗: Up to 28 days
The DLT evaluable analysis set includes all participants in the dose-finding part of the study who have received the target doses of anti-BCMA CAR-T cell product, and who have either experienced a DLT or were followed for the full DLT evaluation period (within 28 days following infusion of CAR-T cells targeting BCMA). The MTD is defined as the dose level immediately below that in which ≥ 2/6 participants experience a DLT.
Best Overall Response Rate (BORR) (Dose expansion + MTD dose escalation cohort)
时间窗: Up to 12 months following CAR-T infusion
ORR is defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), as per International Myeloma Working Group (IMWG) criteria, as best overall response over the total population. ORR will be reported as proportion with 90% binomial confidence interval for the expansion cohort including the patients on MTD in the dose escalation cohort(s).
Proportion of participants with of severe neurologic events (Dose Expansion)
时间窗: From initiation of study treatment to 12 months following CAR-T infusion, approximately 13 months total
Incidence of severe neurologic events defined as grade 2 or higher will be reported as a proportion of the total participants by group.
次要结局
- Overall Response Rate (ORR) - Long term(Up to 15 years)
- Median Duration of Response (DoR) - Beginning of response(Up to 15 years)
- Median Progression-free Survival from Study Entry (PFS-SE)(up to 15 years)
- Median DoR - First documented response(up to 15 years)
- Median Overall Survival (OS)(up to 15 years)
- Rates of MRD (-) and sustained MRD (-)(Up to 15 years)
- Proportion of participants who produced adequate quantities of product for infusion(From initiation of BCMA CAR T-cell manufacturing to end of infusion, Up to 1 month)
- Proportion of participants who complete Car-T infusion study treatment(From initiation of BCMA CAR T-cell manufacturing to end of infusion, Up to 1 month)
- Proportion of participants with treatment- emergent adverse events - Long Term(Up to 15 years)
研究者
Thomas Martin, MD
Principal Investigator
University of California, San Francisco