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Non-Hodgkin Lymphoma Refractory/ RelapsedPhase 2NCT07271121

Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL

A Phase 2 study testing MB-CART-19.1 in people with Non-Hodgkin Lymphoma Refractory/ Relapsed, run by King Hussein Cancer Center at 1 site in Jordan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients >18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MB-CART-19.1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteJordan
Study dates
12 Feb 2025to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible patients with a diagnosis of aggressive NHL:
  • Patients after progression on at least one standard chemotherapy and one salvage regimen or
  • Patients considered for alloSCT but are found ineligible or
  • Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
  • Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
  • CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry
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  • Age > 18 year up to 75 years old (if deemed fit by treating investigator);
  • Baseline absolute CD3+ T cell count by FACS ≥100/µl;
  • ECOG performance score of 0-2 at screening;
  • No active Hepatitis B, Hepatitis C, HIV I/II
  • No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;
  • Signed and dated informed consent, before conduct of any trial-specific procedure.

Who cannot join

  • Residual CNS disease
  • Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
  • Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
  • History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
  • Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies.
  • Cardiac function: left ventricular ejection faction <50% by echocardiogram,
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  • Renal function: Creatinine clearance <50 mL/min/1.73 m2, by Cockcroft-Gault formula (Cockcroft and Gault 1976) for patients ≥18 years.
  • Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT > 5 times upper limit of normal, unless due to lymphoma liver infiltration in the estimation of the investigator.
  • Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy;
  • Pregnant or breast-feeding females
  • Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, Fludarabine/clofarabine or immunosuppressive (Calcineurin inhibitors) drugs and antibodies or investigational drugs or donor lymphocyte transfusions or radiation therapy within 30 days prior to apheresis, and rituximab within 2 weeks with the exception of Intrathecal chemotherapy is allowed prior to treatment, but should be discontinued 10 days prior to-CART19 infusion to limit the risk of neurotoxicities;
  • Patients of child-bearing or fathering potential not willing to practice an effective form of birth control from the time of enrollment and for three months after dosing of the CARTs;
  • Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials.
  • Other investigational treatment within 4 weeks before CARTs infusion;
  • Cerebral dysfunction, legal incapacity of adult patients;
  • Committal to an institution on judicial or official order.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jordan1 site, 1 recruiting

  • King Hussein Cancer Center

    Amman, 11941

    Dr. Khalid Halahleh, MD, 00962778484088, kh.06314@khcc.jo

    Farah Zahran, MSc Clinical Pharmacy, 00962796420055, fzahran@khcc.jo

    Recruiting

Other trials in Jordan

About this study

Official title: A Phase II Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL

This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients >18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.

Read the detailed description

This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial. The trial includes Adult patients > 18-year-old and up to 75 years old, with CD19+ non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma.

Single infusion of freshly prepared MB-CART19.1 cells manufactured according to Miltinyi Biotec product manufacturing guidelines and good manufacturing product (GMP) of KHCC manufacturing standard operating procedures (SOPs).

The patients will receive one infusion of the MB-CART19.1 product in infusion solution at a final volume adapted to the patients' weight, over a time of approx. 5-20 minutes (intravenous infusion via a large peripheral vein or central line).

The objective of this trial is to assess the efficacy and safety of ex vivo generated MB-CART19.1 in adult patients with relapsed or refractory CD19 positive Non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma

Being tested
MB-CART-19.1
Keywords
Non-Hodgkin Lymphoma Refractory/ Relapsed, MB-CART-19.1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MB-CART-19.1Other

    The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System. CD4+ and CD8+ T-cells will be selected, enriched and activated, followed by lentivirus-based transduction with the CD19 CAR construct. Then the MB-CART19.1 transduced T cells will be expanded and finally formulated.

Study groups in NCT07271121
Study groupRoleWhat they receive
MB-CART-19.1ExperimentalOne dose of fresh MB-CART-19.1 at dose level 1- 3x10^6/kg ABW for patients. The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System
Receives: Other: MB-CART-19.1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

    ORR in NHL patients defined as the rate of overall response (CR or PR)

    Measured: on week 4 and at month 3 in patients not achieving CR on week 4

Secondary outcomes (8)

  1. Safety and toxicity

    Safety and toxicity of MB-CART19.1, Overall incidence and severity of adverse events

    Measured: From enrolment to the end of follow up at one year

  2. CRS

    The incidence rate of CRS

    Measured: From enrolment to the end of follow up at one year

  3. Disease-free survival

    Disease-free at 1 year after MB-CART 19.1 in patients not receiving alloHCT

    Measured: at 1 year after receiving study treatment

  4. Duration of response

    Duration of response

    Measured: From enrolment to end of follow up at one year

  5. ICANS

    The incidence rate of ICANS

    Measured: From enrolment to the end of follow up at one year

  6. relapse rate

    relapse rate

    Measured: From enrolment to the end of follow up at one year

  7. time to relapse

    time to relapse

    Measured: From enrolment to the end of follow up at one year

  8. overall survival

    overall survival at 1 year after MB-CART 19.1 in patients not receiving alloHCT

    Measured: at 1 year after receiving study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start12 Feb 2025
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271121
Sponsor's protocol ID
24 KHCC 192
Status last verified
Dec 2025
First submitted
24 Nov 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: to maintain privacy and confidentiality of personal data

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MB-CART-19.1 in people with Non-Hodgkin Lymphoma Refractory/ Relapsed, run by King Hussein Cancer Center at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: on week 4 and at month 3 in patients not achieving CR on week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07271121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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