RecruitingPhase 1Phase 2NCT03676504

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial


Sponsor

University Hospital Heidelberg

Enrollment

68 participants

Start Date

Sep 7, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\^7 transduced cells/m\^2) after lymphodepletion with fludarabine and cyclophosphamide.


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a third-generation CAR T-cell therapy — where a patient's own immune cells are genetically reprogrammed to hunt and destroy a protein called CD19 found on certain blood cancer cells — for people whose blood cancer has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 years or older with a confirmed CD19-positive blood cancer: this includes acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL) - Your cancer has relapsed (come back) or is refractory (not responding) to prior treatment - You are in adequate health to receive the therapy - You have confirmed CD19 expression on your cancer cells **You may NOT be eligible if...** - Your cancer involves the brain or spinal fluid (CNS disease) - You have serious organ problems (heart, liver, or kidneys) - You have active severe infections - You are pregnant or breastfeeding - You have previously received CAR T-cell therapy targeting CD19 and are ineligible for retreatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19.CAR T Cells

Dose Level 1: 1×10\^6 transduced cells/m\^2; Dose Level 2: 5×10\^6 transduced cells/m\^2; Dose Level 3: 20×10\^6 transduced cells/m\^2; Dose Level 4: 5x10\^7 transduced cells/m\^2; Dose Level 5: 10x10\^7 transduced cells/m\^2; Dose Level 6: 20x10\^7 transduced cells/m\^2

DRUGFludarabine

3 days of fludarabine 30 mg/m\^2/day

DRUGCyclophosphamide

3 days of cyclophosphamide 500 mg/m\^2/day


Locations(2)

University Hospital Heidelberg

Heidelberg, Germany

University Hospital Heidelberg

Heidelberg, Germany

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NCT03676504


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