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CAR T-Cell Immunotherapy for  Recurrent/Refractory Mantle Cell Lymphoma (MCL) 

Phase II Clinical Trial (ZUMA-2)

CAR-T treatments show promising results in a number of blood cancers, including Non-Hodgkin Lymphomas (NHLs). In-fact, the FDA already approved a CAR-T product for a 'relative' of MCL- the Diffuse Large B Cell Lymphoma. Based on some-what slimier expression of antigens between the different types of B cell NHL, CAR-T is now being evaluated for other NHL types also- including MCL. 

Clinical trials evaluating CAR-T for MCL patients are scarce when compared to other types of NHLs. Partly due to the rarity of this type of disease and the relatively recent 'clinical discovery' of CAR-T  treatments.

Phase II Open Clinical Trial 

Through both our partner hospitals in Beijing and the trial sponsor, Hebei Senlang BIOTECHNOLOGY Co., LTD, we at Global Healthcare Direct gained a direct access to the clinical trial recruitment process. 

Study Type: Interventional  (Clinical Trial)

Estimated Enrollment: 100 participants

Intervention Model Description: Single Group Assignment

Masking: Open-label trial

Primary Purpose: Treatment

Ages Eligible for Study:  18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

How to apply for the Mantle Cell Lymphoma (MCL) CAR-T trial?

Fill in the below form. Add a short description of your case history and of your current condition. Our case manager will contact you shortly and guide you through.

Choosing to participate in a medical trial is an important personal decision.

Talk with your doctors and family members or friends about deciding to join a study!

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Inclusion Criteria:

  1. Up to 5 prior regimens for mantle cell lymphoma (MCL). Prior therapy must have included:

  • Anthracycline or bendamustine-containing chemotherapy and

  • Anti-CD20 monoclonal antibody therapy and

  • Ibrutinib or acalabrutinib

  1. At least 1 measurable lesion

  2. Platelet count ≥ 75,000/uL

  3. Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

  4. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

  5. Baseline oxygen saturation >92% on room air.

 

Exclusion Criteria:

  1. Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing

  2. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement

  3. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

What's next?

  1. Contact us: fill this form, send an email or give us a call.

  2. Send us your medical documents. We will translate and forward them to the hospital's experts.

  3. We will send you the various possible treatment plans and prices, and help you select the best option for you.

  4. If you’d like, we can help in organizing your flights and accommodation.

  5. Our personal attendant will meet you at the arrival gate and accompany you throughout the course of your treatment.

  6. We will send the translated release documents and keep in touch with you even after you leave.

 

Always here for you,

The GHD Team 

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