MT2017-45: CAR-T Cell Therapy for Heme Malignancies

NCT ID: NCT03642626

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2028-06-01

Brief Summary

This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.

Conditions

Acute Lymphoblastic Leukemia; Large B-cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)

Group Type: EXPERIMENTAL

KYMRIAH

Intervention Type: DRUG

FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells

Fludarabine 30mg/m2 4 doses

Intervention Type: DRUG

30 mg/m2 IV daily for 4 doses

Cyclophosphamide 500 mg/m2; 2 doses

Intervention Type: DRUG

500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine

ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)

Group Type: EXPERIMENTAL

YESCARTA

Intervention Type: DRUG

CD19-directed genetically modified autologous T cell immunotherapy

Fludarabine 30mg/m2 3 doses

Intervention Type: DRUG

30 mg/m2 IV daily for 3 doses

Cyclophosphamide 500 mg/m2; 3 doses

Intervention Type: DRUG

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)

Group Type: EXPERIMENTAL

KYMRIAH

Intervention Type: DRUG

FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells

Fludarabine 25mg/m2 3 days

Intervention Type: DRUG

25 mg/m2 i.v. daily for 3 days

Cyclophosphamide 250 mg/m2; 3 days

Intervention Type: DRUG

250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine

Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)

Group Type: EXPERIMENTAL

Fludarabine 30mg/m2 3 doses

Intervention Type: DRUG

30 mg/m2 IV daily for 3 doses

Cyclophosphamide 500 mg/m2; 3 doses

Intervention Type: DRUG

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

Tecartus

Intervention Type: DRUG

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells

Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)

Group Type: EXPERIMENTAL

Fludarabine 30mg/m2 3 doses

Intervention Type: DRUG

30 mg/m2 IV daily for 3 doses

Cyclophosphamide 500 mg/m2; 3 doses

Intervention Type: DRUG

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

Breyanzi Injectable Product

Intervention Type: DRUG

Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.

Arm F: Abecma for relapsed or refractory multiple myeloma

Group Type: EXPERIMENTAL

Fludarabine 30mg/m2 3 doses

Intervention Type: DRUG

30 mg/m2 IV daily for 3 doses

Cyclophosphamide 500 mg/m2; 3 doses

Intervention Type: DRUG

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

Abecma, Intravenous Suspension

Intervention Type: DRUG

Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.

Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)

Group Type: EXPERIMENTAL

Fludarabine 25mg/m2 3 days

Intervention Type: DRUG

25 mg/m2 i.v. daily for 3 days

Tecartus

Intervention Type: DRUG

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells

Cyclophosphamide 900 mg/m2; 1 day

Intervention Type: DRUG

Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS

Interventions

KYMRIAH

FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells

Intervention Type: DRUG

YESCARTA

CD19-directed genetically modified autologous T cell immunotherapy

Intervention Type: DRUG

Fludarabine 30mg/m2 4 doses

30 mg/m2 IV daily for 4 doses

Intervention Type: DRUG

Cyclophosphamide 500 mg/m2; 2 doses

500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine

Intervention Type: DRUG

Fludarabine 30mg/m2 3 doses

30 mg/m2 IV daily for 3 doses

Intervention Type: DRUG

Cyclophosphamide 500 mg/m2; 3 doses

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

Intervention Type: DRUG

Fludarabine 25mg/m2 3 days

25 mg/m2 i.v. daily for 3 days

Intervention Type: DRUG

Cyclophosphamide 250 mg/m2; 3 days

250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine

Intervention Type: DRUG

Tecartus

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells

Intervention Type: DRUG

Abecma, Intravenous Suspension

Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.

Intervention Type: DRUG

Cyclophosphamide 900 mg/m2; 1 day

Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS

Intervention Type: DRUG

Breyanzi Injectable Product

Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.

Intervention Type: DRUG

Other Intervention Names

tisagenlecleucel; Brexucabtagene Autoleucel

Eligibility Criteria

Inclusion Criteria

• Age and Disease Status

• Must be age 0-25 years (for Arm A Kymriah) or >18 years (Arm G Tecartus)
• Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these:

• Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or
• Patients with persistent minimal residual disease (MRD >0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or
• Patients in 2nd or greater relapse of B-ALL or
• Patients with persistent CNS leukemia, or
• Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or
• Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory.
• Performance Status

• Arm A: Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2
• Organ Function

• Renal function defined as:

• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:

** ALT ≤ 5 times the ULN for age (unless due to disease)

** Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN

• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

• Age and Disease Status

• Adult patients (age ≥ 18 years)Patients must be ≥18 years of age
• One of the following histologies and expression of CD19 by tumor cells:

** diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or

** primary mediastinal large B-cell lymphoma, or

** high grade B-cell lymphoma, or

** DLBCL arising from follicular lymphoma

• Disease status:

** Chemotherapy refractory disease after ≥2 lines of chemotherapy, or

** Relapsed with no remission after ≥1 lines of salvage chemotherapy, or

** Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy

• Measurable disease at time of apheresis: Nodal lesions or extranodal lesion
• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Renal function defined as:

** A serum creatinine of ≤1.5 x ULN OR

** eGFR ≥ 50 mL/min/1.73 m2

• Liver function defined as:

• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :

• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

• Age and Disease Status

• Adult patients (age ≥ 18 years)
• with relapsed or refractory (r/r) large B-cell lymphoma, including

• diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
• high grade B-cell lymphoma
• and DLBCL arising from follicular lymphoma.
• Disease status:

• after two or more lines of systemic therapy or
• relapse after autologous HCT
• Performance Status

• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Organ Function

• Renal function defined as:

• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m^2
• Liver function defined as:

• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :

• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

• Age and Disease Status

• with relapsed or refractory (r/r) mantle cell lymphoma, including
• prior anthracycline or Bendamustine containing therapy
• prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb)
• not a candidate or relapse after autologous HCT
• active disease at enrollment
• Performance Status

*ECOG performance status 0-1

• Organ Function

• Renal function defined as:

• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:

• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
• Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

• Age and Disease Status

• Adult patients (age ≥ 18 years)
• with relapsed or refractory disease after two or more lines of systemic therapy, including

• diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma),
• high-grade B-cell lymphoma,
• primary mediastinal large B-cell lymphoma,
• follicular lymphoma grade 3B
• Performance Status

*ECOG performance status 0-2

• Organ Function

• Renal function defined as:

• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 30 mL/min/1.73 m2
• Liver function defined as:

• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:

• Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

• Age and Disease Status

• Adult patients (age ≥ 18 years)
• Relapsed (progression after prior partial or complete remission) or refractory multiple myeloma
• Evidence of active disease (medullary or extramedullary)
• Prior therapy (Failure or intolerance to) with an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody
• Performance Status

*ECOG performance status 0-1

• Organ Function

• Renal function defined as:

• A serum creatinine of ≤2 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:

• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:

• Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
• CNS 2A
• CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment.
• Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1

ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection (controlled HIV is permissible)
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe.

ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active or inactive HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe

ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
• Patient has taken one of the prohibited concomitant medications within the timeframe

ARM E: Breyanzi "lisocabtagene maraleucel" for relapsed or refractory large B-cell lymphoma

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
• Patient has taken one of the prohibited concomitant medications within the timeframe

ARM F: Abecma "Idecabtagene Vicleucel" for relapsed or refractory multiple myeloma

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
• Patient has taken one of the prohibited concomitant medications within the timeframe

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronika Bachanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MT2017-45

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2020-04527

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017LS118

Identifier Type: -

Identifier Source: org_study_id