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Recruiting Early Phase 1

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

NCT04662294 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2021-11-18
Last updated
2021-11-04

Condition(s) studied

Acute Myeloid LeukemiaNon-hodgkin's LymphomaMultiple Myeloma

Investigational drug(s) / intervention(s)

CD70 CAR T-cells

CD70 CAR T-cells: Each subject receive CD70 CAR T-cells by intravenous infusion

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Inclusion criteria only for AML: 1. Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); 2. Relapsed or refractory CD70+ AML (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry); 4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; 5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 7. Estimated survival time ≥ 3 months; 8. ECOG performance status 0 to 2; 9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Inclusion criteria only for NHL: 1. No gender and age limit; 2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016); 3. Relapsed or refractory CD70+ NHL (meeting one of the following conditions): 1. No response or relapse after second-line or above chemotherapy regimens; 2. Primary drug resistance; 3. Relapse after auto-HSCT; 4. At least one assessable tumor lesion per Lugano 2014 criteria Inclusion criteria only for MM: 1. Histologically confirmed diagnosis of CD70 multiple myeloma (MM): 1. According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma 2. Cases with recurrent positive minimal residual disease; 3. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. No gender and age limit; 3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. Estimated survival time ≥ 3 months; 7. ECOG performance status 0 to 2; 8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Common inclusion criteria : 1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 4. Estimated survival time ≥ 3 months; 5. ECOG performance status 0 to 2; 6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent - Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; 7. Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies; 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 or interfere with the results of study. -

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) — Baseline up to 28 days after CD70 targeted CAR T-cells infusion
    Adverse events assessed according to NCI-CTCAE v5.0 criteria
  • Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after CD70 targeted CAR T-cells infusion
    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04662294 on ClinicalTrials.gov ↗ ← All trials in China