Please assess the completion status of the following clinical trial:

Trial Title: RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria for Enrollment:~A subject may participate in the study if all the following criteria is met:~* Patients with CD19+ malignancies that are refractory to or relapsed after current standard treatment (including allogeneic or autologous HSCT) and not suitable for other treatment options, such as second-time HSCT. CD19+ malignancies include:~  1. Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (ALL):~     1. Refractory ALL is defined as failure to achieve CR at the end of induction.~    2. Relapsed ALL is defined as reappearance of blasts in the blood or bone marrow (≥ 5%) or in any extramedullary site after a CR.~ 2. Relapsed/Refractory B-cell originated Non-Hodgkin Lymphoma (NHL) including 1) de-novo diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, 2) large-B cell lymphoma transformed from indolent lymphomas, 3) follicular lymphoma of all grades, 4) mantle cell lymphoma, and 5) CD20(+) high-grade B-cell lymphomas. Refractory disease for lymphoma is defined as:~     1. Progressive disease or stable disease lasting \< 6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence \< 12 months after prior autologous HSCT.~    2. Prior therapy must have included an anti-CD20 monoclonal antibody-containing regimen and an anthracycline-containing chemotherapy regimen~    3. For patients with transformed follicular lymphoma (TFL), prior chemotherapy for follicular lymphoma and subsequent refractory disease after transformation to DLBCL.~    4. At least one measurable lesion, demonstrating that the nodal lesion is ≥ 1.5 cm in the longest diameter or the extranodal lesion is ≥ 1.0 cm in the longest diameter, according to the Lugano Classification (2014).~* Patients must have received at least 2 prior lines of therapy. HSCT (allogeneic or autologous) can be accounted as one of the prior line therapy, and the subjects must have been at least 3 months from prior HSCT.~* Karnofsky Performance Scale ≥ 60~* Patient able to provide written informed consent for participating in the study~* Age ≥ 20 years and ≤ 75 years old at the time of providing informed consent~* Patients shall be at least 3 weeks from the last cytotoxic chemotherapy before apheresis. Short-acting targeted therapies (e.g., tyrosine kinase inhibitors) must be stopped \> 72 hours before apheresis.~* Monoclonal antibody use including Anti-CD20 therapy has been discontinued at least 4 weeks before leukapheresis and CAR-T cells infusion except for systemic inhibitory/stimulatory immune checkpoint therapy. Immune checkpoint therapy has been discontinued at least 3 half-lives before leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).~* Absolute lymphocyte count (ALC) ≥ 1.0x109/L and absolute number of CD3+ T cells (ATC) ≥ 0.3x109/L, absolute neutrophil count (ANC) ≥ 1.0 x109/L for lymphoma and ANC ≥ 0.5 x109/L for ALL, platelets ≥ 50.0 x109/L, hemoglobin ≥ 80.0 g/L within 7 days before apheresis.~* Adequate organ function demonstrated by the following:~  1. Renal: serum creatinine \<2 x upper limit of normal (ULN)~ 2. Hepatic: ALT/AST ≤ 2.5 x ULN or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL.~ 3. Cardiac: no clinically significant ECG findings, hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram~ 4. Pulmonary: baseline oxygen saturation \> 90% on room air~* 10. Not receiving anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell immunosuppressive antibodies, donor-lymphocyte infusion or T-cell infusion for the past 3 weeks before apheresis;~* Negative serology for Anti-HTLV-I / HTLV-II (DHTLV I/II)~Exclusion Criteria for Enrollment~A subject who met any of the following criteria is not eligible to enter the study:~* Received previous treatment with anti-CD19 therapy;~* Is with a history of CNS malignancy and/or active CNS diseases;~* Has previous or concurrent malignancies other than CD19+ malignancies;~* Has active neurological, autoimmune, or inflammatory disorders;~* Has clinically significant cardiac diseases, or cardiac arrhythmia not controlled with medical treatment;~* Has cardiac involvement with lymphoma;~* Has any active infections, conditions, and diseases that may interfere with the assessment of safety and efficacy of the study deemed by the investigator or designee;~* Received live vaccine within 6 weeks of the screening~* Received radiation therapy within 2 weeks of the planned CAR-T cells infusion;~* Is with positive serology for HIV;~* Is with positive hepatitis B or hepatitis C infection, defined as positive HBs Ag or positive Anti-HCV Ab;~* Active graft versus host disease (GVHD) ≥ grade 2 using the CIBMTR Acute GVHD Grading System or requiring systemic steroid therapy greater than physiologic dosing; Note: Overall grading of GVHD is based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8, see the GVHD Grading and Staging table at CIBMTR Forms Instruction Manual (Last updated: 2020/03/10), page 301-303 (Available at https://www.cibmtr.org/manuals/fim, accessed on 08 Apr 2020).~* Use of investigational medicinal product within 30 days before the screening;~* Positive beta HCG in female of child-bearing potential (defined as not post-menopausal for 12 months) or history of previous surgical sterilization or lactating females.~* Patients with known allergy to mouse products or cetuximab.~Inclusion Criteria for Lymphodepletion and T-Cell Infusion:~* Prior to Lymphodepletion (LD):~  1. Patients must have no evidence of clinically significant infection;~ 2. No acute neurological toxicity \>grade 1 (with the exception of peripheral sensory neuropathy) prior to conditioning chemotherapy;~ 3. No clinically significant cardiac dysfunction;~ 4. Serum creatinine \< 2x ULN;~ 5. No evidence of grade ≥2 acute GVHD;~ 6. Pulmonary: oxygen saturation \> 90% on room air;~ 7. Adequacy of T cells apheresis products to manufacture CAR-T product.~* Prior to CAR-T cells infusion:~  1. Patients shall be at least 4 weeks from the last cytotoxic chemotherapy (excluding the study mandated lymphodepleting chemotherapy) before infusion. Short-acting targeted therapies (e.g., tyrosine kinase inhibitors) must be stopped \> 72 hours before infusion.~ 2. At least 4 weeks from anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell immunosuppressive antibodies, donor-lymphocyte infusion or T-cell infusion;~ 3. Steroids, if given as GVHD therapy, must be stopped \>72 hours prior to infusion. However, the following physiological replacement doses of steroids are allowed: \< 6-12 mg/m2/day hydrocortisone or equivalent.~ 4. Non-hematologic toxicity grade ≥2 (CTCAE version 5) related to the lymphodepleting chemotherapy until the toxicity has resolved to grade ≤1 and the subject is afebrile;~ 5. No grade \>2 neurologic, pulmonary, cardiac, gastrointestinal, renal, or hepatic (excluding albumin) toxicity;~ 6. Adequacy of the CAR-T cells for infusion.~Exclusion Criteria For Lymphodepletion and T-Cell Infusion:~A subject who meets any of the following criteria should not undergo LD or infusion of CAR-T cells.~* New onset of cardiac arrhythmia not uncontrolled with medications;~* Hypotension warrants the use of vasopressor;~* Active infections within 1 week prior to CAR-T infusion that necessitate the use of oral or intravenous anti-infective treatments; subjects with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible as long as there is no evidence of active infection.~* Presence of CNS or neurological abnormalities;~* Received HSCT after screening or planned to receive HSCT during the study period;~* Any conditions not suitable for the CAR-T cells infusion in the PI or designee's judgement.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Infusion RPM CD19-mbIL15-CAR-T cell (Type: EXPERIMENTAL): In this study, anti-CD19 autologous chimeric antigen receptor T-cells infusion produced by rapid personalized manufacture are used to treat patients with relapsed/refractory Advanced Lymphoid Malignancies.~Route of administration: Intravenous injection.~Lymphodepletion conditioning:~Lymphodepletion will be conducted several days prior to RPM CD19-mbIL15-CAR-T cell infusion.~A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy