CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Last updated: October 26, 2021
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Non-hodgkin's Lymphoma

Acute Myeloid Leukemia

Treatment

N/A

Clinical Study ID

NCT04662294
CD70-001
  • All Genders

Study Summary

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion criteria only for AML:

  1. Histologically confirmed diagnosis of CD70 AML per the US National ComprehensiveCancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
  2. Relapsed or refractory CD70+ AML (meeting one of the following conditions):
  3. CR not achieved after standardized chemotherapy;
  4. CR achieved following the first induction, but CR duration is less than 12months;
  5. Ineffectively after first or multiple remedial treatments;
  6. 2 or more relapses;
  7. The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
  8. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  9. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  10. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  11. Estimated survival time ≥ 3 months;
  12. ECOG performance status 0 to 2;
  13. Patients or their legal guardians volunteer to participate in the studyand sign theinformed consent. Inclusion criteria only for NHL:
  14. No gender and age limit;
  15. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL,PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
  16. Relapsed or refractory CD70+ NHL (meeting one of the following conditions):
  17. No response or relapse after second-line or above chemotherapy regimens;
  18. Primary drug resistance;
  19. Relapse after auto-HSCT;
  20. At least one assessable tumor lesion per Lugano 2014 criteria Inclusion criteria only for MM:
  21. Histologically confirmed diagnosis of CD70 multiple myeloma (MM):
  22. According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis wasrecurrent / refractory multiple myeloma
  23. Cases with recurrent positive minimal residual disease;
  24. Extramedullary leision which is hard to be eradicated by chemotherapy orradiotherapy.
  25. No gender and age limit;
  26. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal,creatinine ≤ 176.8 umol/L;
  27. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  28. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  29. Estimated survival time ≥ 3 months;
  30. ECOG performance status 0 to 2;
  31. Patients or their legal guardians volunteer to participate in the studyand sign theinformed consent. Common inclusion criteria :
  32. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal,creatinine ≤ 176.8 umol/L;
  33. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  34. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  35. Estimated survival time ≥ 3 months;
  36. ECOG performance status 0 to 2;
  37. Patients or their legal guardians volunteer to participate in the study and sign theinformed consent -

Exclusion

Exclusion Criteria:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, exceptfor the patients recently or currently receiving inhaled steroids;
  7. Previously treated with any CAR-T cell product or other geneticallymodified T celltherapies;
  8. Creatinine >2.5mg/dl, or ALT / AST>3 times of normal amounts, or bilirubin>2.0 mg/dl;
  9. Other uncontrolled diseases that were not suitable for this trial;
  10. Patients with HIV infection;
  11. Any situations that the investigator believes may increase the risk of patients orinterfere with the results of study. -

Study Design

Total Participants: 108
Study Start date:
November 18, 2021
Estimated Completion Date:
January 15, 2027

Study Description

This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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