NCT06213636: BAH241

Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).

Recruiting now Phase 1, PHASE2 Last updated 6 August 2025

What this trial tests

Phase 1, PHASE2 trial testing CD19/CD22-CAR T cells in Acute Lymphoblastic Leukemia, Adult B-Cell in 75 participants. Currently enrolling.

Timeline

10 July 2024

Primary endpoint
10 February 2027

10 December 2028

Quick facts

Lead sponsor	Essen Biotech
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	10 July 2024
Primary completion	10 February 2027
Estimated completion	10 December 2028
Sites	1 location across China

Drugs / interventions tested

• CD19/CD22-CAR T cells

Conditions studied

• Acute Lymphoblastic Leukemia, Adult B-Cell — all drugs for Acute Lymphoblastic Leukemia, Adult B-Cell →
• Acute Lymphoblastic Leukemia, in Relapse — all drugs for Acute Lymphoblastic Leukemia, in Relapse →
• Non-Hodgkin Lymphoma, B-cell — all drugs for Non-Hodgkin Lymphoma, B-cell →
• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →

Sponsor

Essen Biotech — full company profile →

Who can join

Adults 2 to 90, any sex, with Acute Lymphoblastic Leukemia, Adult B-Cell or Acute Lymphoblastic Leukemia, in Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II.

Eligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
2. Advances in CAR-T therapy for central nervous system tumors.
   Zhou D, Zhu X, Xiao Y. · · 2024 · cited 15× · PMID 39506843 · DOI 10.1186/s40364-024-00679-6
3. Drug resistance in cancer: molecular mechanisms and emerging treatment strategies.
   Li J, Hu J, Yang Y, Zhang H, et al · · 2025 · cited 5× · PMID 41247642 · DOI 10.1186/s43556-025-00352-w
4. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
   Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
5. Unraveling the immune microenvironment in primary CNS lymphoma.
   Lorenzen S, Zeremski V, Berisha M, Mougiakakos D, et al · · 2026 · PMID 42226261 · DOI 10.1186/s40364-026-00945-9
6. T cell-inspired therapeutic delivery platforms: From nanomedicines to cell therapy.
   Jan N, Shah H, Khan S, Khan NU, et al · · 2026 · PMID 41732384 · DOI 10.1016/j.mtbio.2026.102909