NCT02050347Fut, nem toboroz1. fázis
Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)
Phase I Study of Activated T Lymphocytes Expressing Chimeric Antigen Receptors for Therapy of Relapsed CD19-Positive Malignancies Post-Allogeneic Hematopoietic Stem Cell Transplantation Infused Only After Engraftment (CARPASCIO)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment (including the best treatment known for these cancers). Because there is no standard treatment for this cancer at this time, subjects are asked to volunteer to be in a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. The T lymphocytes will also contain CD28, which stimulates T cells and makes them last longer. Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and leukemia when the cells are made from the patients affected by these diseases. In this study, investigators are going to see if this treatment works even better when they make these cells from a healthy stem cell donor. If investigators are not able to collect blood from the stem cell donor, they will collect blood from the subject to make the CD19/CD28 chimeric receptor-T cells. These CD19/CD28 chimeric receptor T cells are investigational products not approved by the FDA. The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to see how long T cells with this chimeric receptor last, to learn what the side effects are, and to see whether this therapy might help people with lymphoma or leukemia after a stem cell transplantation from a donor.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 7 (tényleges)
- Első benyújtás
- 2014. jan. 29.
- Kezdés
- 2014. ápr.
- Elsődleges befejezés
- 2019. okt.
- Fő szponzor
- Baylor College of Medicine
- NCT-szám
- NCT02050347
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 7
- 2014. ápr. és az elsődleges befejezés (2019. okt.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Currently taking corticosteroids (>0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD.
Más betegség
- Severe intercurrent infection.
- History of hypersensitivity reactions to murine protein-containing products.
Egyéb
- Evidence of GVHD > grade II.
- Pregnant or lactating.
Kiket keres a vizsgálat
- PROCUREMENT
- Group A: CD19+ B-ALL undergoing allogeneic HSCT or Group B: CD19+ B cell CLL or NHL undergoing allogeneic HSCT
- Life expectancy of ≥12 weeks.
- Patient has an appropriate donor identified for hematopoietic stem cell transplantation
- TREATMENT
- Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)
- Residual disease at the time of transplant (bulky or minimal) or post transplant relapse as evidenced by PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy or in the peripheral blood. MRD will be defined as detection in blood or marrow of any of the following:
- Any leukemia specific marker (such as t(9:22) or t(4:11)) documented in the patient's leukemia cells pre transplant on a post transplant evaluation.
- An immune globulin rearrangement known to be a disease marker for this patient post transplant.
- A leukemia specific phenotype post transplant at a level of ≥ 0.01%
- Mixed donor chimerism (any level)
- Life expectancy ≥ 6 weeks
- Karnofsky/Lansky score ≥ 50%.
- Bilirubin ≤ 2 times the upper limit of normal.
- AST ≤ 3 times the upper limit of normal.
- Estimated GFR > 50 mL/min
- Hgb ≥ 7.0 (can be a transfused value)
- Pulse oximetry of > 90% on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after ATL infusion. The male partner should use a condom.
- Available allogeneic activated peripheral blood T cell products with >=15% expression of CD19.CAR-CD28ζ determined by flow cytometry (cell dose is based on total cell numbers and not individual antileukemic cell numbers).
- No other investigational antitumor therapy for one month prior to entry in this study.
- Patients or legal guardians must sign an informed consent.
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Houston Methodist Hospital | Houston | Egyesült Államok | Ismeretlen állapot |
| Texas Children's Hospital | Houston | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.