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NCT05168748Visszavonva1. fázis

CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia

Phase I, Open Label, Multicenter, Dose Escalation and Expansion Study of IMJ995 in Acute Lymphoblastic Leukemia

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2022. dec. 21.

Megadott ok: Sponsor's decision

Rövid összefoglaló (regiszter, angolul)

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).

Állapot (regiszter)
Visszavonva
Fázis (regiszter)
1. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
0 (tényleges)
Első benyújtás
2021. nov. 3.
Kezdés
2023. jan. 24.
Elsődleges befejezés
2026. aug. 13.
Fő szponzor
Novartis Pharmaceuticals
NCT-szám
NCT05168748
EudraCT-szám
2021-000677-89

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Korábbi kezelés

  • Allogeneic HCT within 12 weeks prior to screening.
  • Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome.

Más betegség

  • Presence of isolated extra-medullary disease, testicular involvement or bulky disease
  • History of active neurological auto immune or inflammatory disorders
    • Other protocol-defined inclusion/exclusion criteria may apply.

Egyéb

  • Patients with Burkitt's lymphoma/leukemia

Kiket keres a vizsgálat

  • All patients:
  • Evidence of CD19 and/or CD22 cell surface expression on B-ALL blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry.
    • Pediatric, adolescent and young adult ALL patients:
  • 1 - 29 years of age at the time of informed consent form (ICF) signature.
  • Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT.
  • Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression occurred or have not been eligible for CD19 directed CAR-T treatment.
  • Lansky (age < 16 years), Karnofsky (age 16-25 years) performance status ≥ 60%. ECOG (age >25 years) performance status that is either 0 or 1 at screening.
    • Adult ALL patients aged ≥30 years:
  • ≥30 years of age at the time of informed consent form (ICF) signature.
  • Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following:
    • After allogeneic HCT
    • After 2 or more lines of treatment, including blinatumomab and/or inotuzumab
    • Primary refractory disease (defined as failure to achieve a CR at the end of at least 1 induction chemotherapy)
    • First relapse occurring within 12 months from first remission
  • ECOG performance status that is either 0 or 1 at screening.

Életkor a regiszterben: 1 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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