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New treatment option for T-cell Acute Lymphoblastic Lymphoma
Official title Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
ClinicalTrials.gov ID: NCT03081910
What this study is testing
What is Autologous CD5.CAR/28zeta CAR T cells?
Autologous CD5.CAR/28zeta CAR T cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for t-cell acute lymphoblastic lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 75
You may be able to join if
- Procurement for the Patient Referred patients (Group A - NOW CLOSED) or their previous HSCT donors (Group B) will initially be consented for...
- Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL...
- Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited...
- Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
- For T-NHL people, eligibility will be confined to disease stages where allogeneic HSCT is indicated.
You likely can't join if
- for the Patient (Group A)
- Active infection requiring antibiotics.
- Active infection with HIV
- History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with...
- Donor must be prior hematopoietic stem cell transplant donor for patients relapsed post-allogeneic HSCT. Prior transplant donors will be screened...
- Informed consent explained to, understood by and signed by donor/LAR. Donor/LAR given copy of informed consent. Treatment Inclusion Criteria Patients...
See the full eligibility criteria
Who can join
- Procurement for the Patient Referred patients (Group A - NOW CLOSED) or their previous HSCT donors (Group B) will initially be consented for procurement of blood for generation of the transduced ATL. Patient eligibility...
- Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL)...
- Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution
- Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
- For T-NHL people, eligibility will be confined to disease stages where allogeneic HSCT is indicated.
- CD5-positive tumor (result can be pending at this time). \> 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory.
- Age ≤75 years old. NOTE: The first six (6) patients treated on the study should be adults (\>18 yrs of age).
- Life expectancy of greater than 12 weeks.
- Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Hgb greather than or equal to 7.0 g/dL (can be transfused)
- If pheresis required to collect blood:
- Creatinine \<1.5 × upper limit normal
- AST \<1.5 × upper limit normal
- PT and APTT \<1.5 × upper limit normal Procurement
What rules you out
- for the Patient (Group A)
- Active infection requiring antibiotics.
- Active infection with HIV
- History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry. Procurement...
- Donor must be prior hematopoietic stem cell transplant donor for patients relapsed post-allogeneic HSCT. Prior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and...
- Informed consent explained to, understood by and signed by donor/LAR. Donor/LAR given copy of informed consent. Treatment Inclusion Criteria Patients must meet the following eligibility criteria to be included for...
- Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL)...
- Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution
- Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
- For T-NHL people, eligibility will be confined to disease stages where allogeneic HSCT is indicated.
- CD5-positive tumor. \>50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory.
- Age \ 18 yrs of age).
- Bilirubin less than 3 times the upper limit of normal.
- AST less than 5 times the upper limit of normal.
- Estimated GFR \> 60 mL/min.
- Pulse oximetry of \> 90% on room air.
- Karnofsky or Lansky score of ≥ 60%.
- Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study.
- ≥ 60 days post-allogeneic HSCT at time of treatment.
- Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent. Treatment Exclusion Criteria
- Currently receiving any investigational agents or having received any tumor vaccines within the previous 6 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Active infection with HIV.
- Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.
- Evidence of acute GVHD \> Grade II or active chronic GVHD \> mild global severity score
- Currently taking corticosteroids for therapy of GVHD at a dose of \>0.5mg/kg prednisone equivalent
- Patients who have received Immunosuppressive Treatment (IST) for GVHD within 28 days of infusion
- Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography...
- CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3; History or presence of any CNS disorder such as a uncontrolled seizure disorder...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.