Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
NCT ID: NCT05211557
Last Updated: 2022-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2021-11-16
2026-08-31
Brief Summary
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Detailed Description
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After enrollment, participants' peripheral blood mononuclear cells will be collected and used to manufacture fhB7H3.CAR-Ts. Before infusion, the patients will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for three consecutive days. Two days later after lymphodepletion, the fhB7H3.CAR-Ts would be given through an abdominal catheter for intraperitoneal infusion. From the day of infusion, participants' peripheral blood and ascites will be collected twice a week in the first month for monitoring the survival of fhB7H3.CAR-Ts and evaluating the therapeutic efficacy. Additional follow-up and examination will be performed monthly for the first three month and then trimonthly until one year. Thereafter, annual follow-up will be completed for 5 years.
In addition, since the fhB7H3.CAR-Ts containing a RQR8 safety-switch which could be targeted and removed by Rituximab. Participants who experience life-threatening toxicities caused by uncontrollable proliferation of fhB7H3.CAR-Ts will receive infusion of Rituximab (Rituxan or Ruxience or Halpryza) to assess the ability of RQR8 safety-switch to eliminate infused fhB7H3.CAR-Ts.
This is an investigator-initiated clinical study to assess first-line clinical performance of novel fhB7H3.CAR-Ts which may help other advanced and recurrent ovarian cancer patients in the future.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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fhB7H3.CAR-T cells
In phase I study, 9 enrolled patients diagnosed with advanced ovarian cancer will receive one-time infusion of fhB7H3.CAR-Ts at the doses of 1×10\^6/kg, 3×10\^6/kg and 5×10\^6/kg, 3 patients for each dose. To further confirm the therapeutic efficacy, in phase II study, 6 enrolled patients will receive an optimal dose (balancing effectiveness and toxicity) of fhB7H3.CAR-Ts. Prior to receiving the infusions, patients will undergo lymphodepletion with fludarabine and cyclophosphamide.
fhB7H3.CAR-Ts
Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.
Other Name: B7H3 targeting chimeric antigen receptor T cells Drug: Fludarabine 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3) Other Name: FLUDARA Drug: Cyclophosphamide 750 mg/m2 i.v. for once (Day -5) Other Name: Cytoxan
Interventions
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fhB7H3.CAR-Ts
Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.
Other Name: B7H3 targeting chimeric antigen receptor T cells Drug: Fludarabine 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3) Other Name: FLUDARA Drug: Cyclophosphamide 750 mg/m2 i.v. for once (Day -5) Other Name: Cytoxan
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent and authorization for release of personal health information
3. Subject has adequate performance status as defined by ECOG score of ≤ 2.
4. Expected life expectancy is no less than 12 weeks.
5. Subjects must have histologically or cytologically confirmed ovarian cancer. And cancer tissue or ascitic cancer cells are measured positive for B7H3 expression.
6. Subjects must have recurrent or refractory disease after or during first-line treatment.
Defined as:
Radiographic progression or Continuous Elevation of CA125.
7. Subjects must have evaluable disease - defined as:
Measurable disease with tumor length ≥ 10mm or enlarged lymph nodes ≥ 15mm according to RECIST v1.1 criteria.
8. Adequate organ function - defined as:
1. Blood routine:
white blood cell count ≥ 3 × 10\^9 / L; neutrophil count ≥ 1.5 × 10\^9 / L; hemoglobin ≥ 9g/dL; platelet count ≥ 80 × 10\^9 / L; INR\< 1.5 × ULN; PT, APTT\< 1.5 × ULN
2. The liver, kidney, lung and cardiopulmonary function:
Urea and serum creatinine ≤ 1.5 × ULN; Left ventricular ejection fraction ≥ 40%; Baseline oxygen saturation ≥ 95%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN.
9. Not pregnant with negative serum pregnancy test within 3 days prior to enrollment.
10. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of highly effective methods of contraception from the time of informed consent until 8 weeks after study treatment discontinuation.
\-
Exclusion Criteria
2. Subject has active infection with HIV, HTLV, HBV, HCV.
3. Subject has severe, uncontrolled intercurrent bacterial, viral or fungal infection.
4. Subject has a history of gastrointestinal perforation, clinical and/or radiographic evidence of bowel obstruction, or intra-abdominal abscess within 3 months prior to starting treatment.
5. Subject has active malignancy under treatment other than ovarian cancer.
6. Subject has Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention.
7. Subject is current using of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent.
8. Subject has not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0).
9. Subject is pregnant or breastfeeding.
10. Unwilling or unable to provide consent/assent for participation in the study. -
18 Years
70 Years
FEMALE
No
Sponsors
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Xuzhou Medical University
OTHER
IIT MediTech (Jiangsu) Co. Ltd
UNKNOWN
The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Junnian Zheng, M.D., Ph.D.
Role: STUDY_DIRECTOR
The Affiliated Hospital of Xuzhou Medical University, Xuzhou Medical University
Longzhen Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Xuzhou Medical University
Gang Wang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Xuzhou Medical University
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XYFY2021-KL184-01
Identifier Type: -
Identifier Source: org_study_id
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