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Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

ConditionRelapsed or Refractory Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJuventas Cell Therapy Ltd.

About this trial

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent is signed by the subject.

Age 18 to 65.

Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).

Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.

Disqualifiers

Active Central Nervous System (CNS) involvement by malignancy.

Isolated extra-medullary disease relapse.

Lymphodepleting Chemotherapy prescribed by the protocol;

Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped > 72 hours prior to CNCT19 infusion;

Trial design

Design model

Single group

Treatments tested in this trial

  • single dose of CNCT19

    Biological/Vaccine

    Dose: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single dose of CNCT19Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).

The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.

Time frame
At 3 months after infusion

Secondary outcomes

1

Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.

MRD negative status as determined using flow cytometry.

Time frame
3 months
2

Overall Remission Rate (ORR) as determined by IRC and Investigators.

The proportion of patients who have achieved CR or CRi.

Time frame
28 days
3

Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.

MRD negative status as determined using flow cytometry.

Time frame
28 days
4

Relapse Free Survival (RFS) as determined by IRC and Investigators.

RFS means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Juventas Cell Therapy Ltd.

Lead sponsor

Source ClinicalTrials.gov
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