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Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma

ConditionLarge B-Cell Lymphoma (LBCL)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. The participant has given consent and signed the informed consent form, and is willing and able to comply with planned visits, research treatments, laboratory tests, and other trial procedures;

Anti-CD20 monoclonal antibody;

Combination chemotherapy containing anthracyclines.

3. Age 18 years and above, both male and female;

Disqualifiers

1. Severe heart failure with left ventricular ejection fraction <50%;

2. History of severe pulmonary dysfunction;

3. Concurrent progressive malignant tumors;

4. Severe infections that cannot be effectively controlled;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19X CAR-T

    Drug

    Eligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10\^6 CAR cells/kg of CAR-T cell infusion.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: CD19X CAR-TOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events

Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.

Time frame
Within 28 days after CAR-T infusion

Secondary outcomes

1

Efficacy indicators

Objective Response Rate (ORR) of tumors

Time frame
At 1 and 3 months after CAR-T infusion
2

Efficacy indicators

Complete Remission (CR) Rate

Time frame
At 1 and 3 months after CAR-T infusion
3

Cell Metabolic Kinetics Indicators

The maximum concentration (Cmax) of the study participants' CAR-T cells in peripheral blood

Time frame
On the 7th, 10th, 14th, and 28th days after treatment
4

Cellular Metabolic Kinetics Indicators

Time (Tmax) at which the study participants' CAR-T cells reach the maximum concentration in peripheral blood

Time frame
On the 7th, 10th, 14th, and 28th days after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: