- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02958397
A Clinical Research of CD33-Targeted CAR-T in Myeloid Malignancies
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Shiqi Li, MD
- Telefonnummer: 0086-13206140093
- E-post: Lystch@qq.com
Studiesteder
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Chongqing
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Chongqing, Chongqing, Kina, 400000
- Rekruttering
- Southwest Hospital of Third Millitary Medical University
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Ta kontakt med:
- Zhi Yang, PhD
- Telefonnummer: 008613206140093
- E-post: Lystch@qq.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- CD33-expressing myeloid malignancy must be assured and must be relapsed or refractory disease. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
- Patients enrolled must have an evaluated score above 60 with KPS.
- CD33 expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
- Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
- Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
- Ability to give informed consent.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
- Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
- Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Patients volunteer to participate in the research.
Exclusion Criteria:
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
- HIV infection.
- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in the research.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Myeloid Malignancies
The trial will be conducted in a manner of simon two-stage design with anti-CD33-CAR-transduced T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with myeloid malignancies.
Only when the expected reaction rate is achieved the 30 patients left can be recruited.
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The first 3 enrolled patients will receive autologous-derived CD33-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy.
If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Adverse Events That Are Related to Treatment
Tidsramme: 3 years
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Determine the toxicity profile of the CD33 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
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3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Reaksjonsrate for behandling
Tidsramme: 3 år
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3 år
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In vivo existence of Anti-CD33 CAR-T cells
Tidsramme: 3 years
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3 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Cheng Qian, MD, PhD, Biotherapy Center of Southwest Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TMMU-BTC-011
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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