Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma

NCT05320081 | Unknown Phase 2

• 1 other identifier: MA-ML-Ⅱ-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The is a phase II, single-arm, open-label clinical study assessing the efficacy and safety of Camrelizumab combined with CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 30 subjects with r/r CD30+ lymphoma。

Conditions

Lymphoma; Relapse/Recurrence

Keywords

CD30 positive

Outcome Measures

Primary Outcomes (2)

• overall response rate

  including complete remission (CR) or partial remission (PR)

  up to 3 months after CAR-T cell infusion

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  To evaluate the safety of camrelizumab combined with CD30 CAR-T in the treatment of relapsed/refractory CD30+ lymphoma.

  up to 90 days

Secondary Outcomes (4)

• overall survival (OS)

  24 months

• Duration of remission (DOR)

  24 months

• Progression-free Survival (PFS)

  24 months

• Time to Remission (TTR).

  12 months

Other Outcomes (1)

• The copy number of CD30 CAR-T cells

  12 months

Study Arms (1)

Camrelizumab combined with CD30 CAR-T

EXPERIMENTAL

This study have only one arm that is Camrelizumab combined with CD30 CAR-T experimental arm.

Biological: CD30 CAR-T; Drug: Camrelizumab

Interventions

CD30 CAR-T BIOLOGICAL

Subjects need to complete a series of checks before reinfusion of CD30 CAR-T cells as baseline information for subjects after non-myeloablative pretreatment. The subject was reinfused with CD30 CAR-T cells (10±3)×10\^6/kg on the 0th day of the first dosing cycle (the investigator decided the specific reinfusion dose based on the subject's own/disease conditions and preparation conditions in vitro ), concurrent oxygen inhalation and monitoring (ECG, blood pressure and blood oxygen monitoring). The reinfusion was completed in about 30 minutes, and the tube was flushed with saline. Note: CAR-T cell infusion and reinfusion dose are based on the subject's condition.

Camrelizumab combined with CD30 CAR-T

Camrelizumab DRUG

Received Camrelizumab treatment on the 15th day after CAR-T cell reinfusion, and then received Camrelizumab treatment every 2 weeks.

Camrelizumab combined with CD30 CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥18 years and ≤70 years，female and male；
• ECOG performance status 0-2；
• Histological or flow cytometry confirmed CD30+ lymphoma \[according to WHO2008 diagnostic standard\]
• Patients with CD30+ lymphoma relapsed after ≥2 lines of systemic treatment (the disease progresses after treatment remission) or refractory ( failed to obtain CR after previous systemic treatment)；
• The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before enrollment, and the treatment-related toxicity has recovered to ≤ Grade 1 (except for alopecia) 4 weeks before enrollment；
• At least 1 evaluable or measurable lesion can be measured according to the LYRIC 2016 evaluation criteria for malignant lymphoma ；
• Sufficient organ and bone marrow function, no serious abnormalities neither in hematopoietic function nor in heart, lung, liver, and kidney functions, and no immune deficiencies;
• The absolute value of neutrophils is ≥1.5×109/L (for patients with bone marrow invasion ≥1.0×109/L);
• Platelets ≥75×109/L (patients with bone marrow invasion ≥50×109/L);
• Hemoglobin ≥9 g/dL;
• Serum creatinine ≤ 1.5× the upper limit of normal (ULN), or creatinine clearance ≥40 mL/min (estimated based on the Cockcroft-Gault formula);
• Serum total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN ( liver invasion);.
• f) Aspartate aminotransferase、Alanine Aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN ( liver invasion);
• Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (the PT and APTT should be within the expected range of anticoagulant therapy at the time of screening if the subject is receiving anticoagulant therapy,).
• Thyroid-stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) are within ±10% of the normal value.

You may not qualify if:

• Lymphoma associated hemophagocytic syndrome;
• Patients diagnosed as primary cutaneous anaplastic large cell lymphoma （ALCL） (patients can be enrolled if ALCL is transformed from other organ involvement);
• Patients with malignant T cells involving bone marrow or peripheral blood;
• Suffered from other malignant tumors in the past 5 years, except for for skin basal cell carcinoma, skin squamous cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ undergoing the radical treatment
• Received CAR-T therapy or other genetically modified cell therapy before screening
• Received other treatments that affect the collection of T cells for when enrolled or within 4 weeks before enrollment;
• Suffer from active autoimmune diseases that require systemic treatment in the past two years (hormone replacement therapy is not considered as systemic treatment, such as type I diabetes, hypothyroidism that requires only thyroxine replacement therapy, patients with low adrenal function or hypopituitarism who need only physiological doses of glucocorticoid replacement therapy);
• Patients with uncontrolled infectious diseases, active viral hepatitis, tuberculosis, and HIV-infected ;
• Known to be allergic to ampicillin, antibodies, cytokines, anti-PD-1/PD-L1 antibodies or pharmaceutical excipients; or have severe allergic reactions to other monoclonal antibodies;
• Previous use of immunosuppressive drugs within 14 days before the first use of the drug, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent physiological doses of other corticosteroids);
• long-term use of systemic hormones (dose equivalent to \>10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids can be enrolled;
• Suffer from uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or bleeding disorders.
• With history of interstitial lung disease or non-infectious pneumonia. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to enroll.
• Patients have other conditions that are not suitable for enrollment according to the judgment of the investigator.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (2)

Department of Hematology Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Recurrence

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianfeng Zhou

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Zhou, MD, PhD

CONTACT

86-13627284963; jfzhou@tjh.tjmu.edu.cn

Xiaoxi Zhou, MD, PhD

CONTACT

86-027-83662686; cello316@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Division of Hematology

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: April 11, 2022
• Study Start: November 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)