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Partnering with oncology teams to deliver advanced cell therapy
CARA Yakhteh collaborates directly with treating hematologists, oncologists, and bone marrow transplantation (BMT) units to provide seamless patient referral pathways, standardized collection protocols, and rigorous cGMP manufacturing for CARTIVATE.
Review key clinical indications, explore the step-by-step physician referral workflow, download management guidelines, and connect directly with our Medical Affairs team.
THERAPEUTIC PROFILE
CARTIVATE clinical scope & target validation
CARTIVATE is an autologous, CD19-directed chimeric antigen receptor (CAR) T-cell therapy developed under IRC regulatory standards for patients with relapsed or refractory B-cell hematologic malignancies.
Biological Target — CD19
CD19 is uniformly expressed throughout normal B-cell ontogeny and across the majority of B-cell malignancies, making it an ideal lineage-specific surface antigen for targeted cytolytic redirection without affecting hematopoietic stem cells.
Clinical Indications
Pediatric and young adult patients up to 25 years with CD19+ B-cell Acute Lymphoblastic Leukemia (B-ALL) that is refractory or in second or later relapse, as well as adult patients with relapsed/refractory aggressive Large B-cell Lymphoma.
cGMP Batch Certification
Manufactured within CARA Yakhteh’s ISO Class 5/7 classified bioprocessing suites. Each patient lot is released only after meeting validated identity, viability, sterility, mycoplasma, and CAR transduction efficiency specifications.
CLINICAL WORKFLOW
How to initiate a patient referral
Our multidisciplinary cell therapy liaison team works closely with your hospital oncology department through three streamlined coordination stages:
Eligibility & Case Review
Evaluate patient history against CD19 status confirmation, ECOG performance status (0–1), adequate renal and hepatic reserve, and lack of uncontrolled active systemic infection. Our medical team is available for peer-to-peer case review.
Leukapheresis & Logistics
Upon referral acceptance, non-mobilized peripheral blood mononuclear cells (PBMCs) are collected via standard leukapheresis at an accredited partner hospital. The apheresis product is transported via validated, temperature-logged cold chain to CARA Yakhteh.
Release & Infusion
Following 3–4 weeks of cGMP transduction, cell expansion, and release certification, the cryopreserved CARTIVATE dose is delivered to the treating hospital for administration following standard lymphodepleting chemotherapy (fludarabine/cyclophosphamide).
QUALITY ASSURANCE & SECURITY
End-to-end chain of custody & quality testing
Autologous cellular therapy demands absolute specimen integrity. CARA Yakhteh operates a zero-failure cold-chain logistics network and comprehensive analytical release testing:
Continuous Temperature-Logged Logistics
Validated dry-shipper and liquid nitrogen cryopreservation systems with 24/7 digital data logging ensure cells remain at cryogenic temperatures throughout inter-city and intra-hospital transit.
- Chain of Identity (COI) dual-barcode verification
- Calibrated real-time GPS & thermal telemetry
- Dedicated clinical dispatch coordinators
Strict Quality Release Specifications
Before any finished lot leaves the manufacturing cleanroom, it must pass a battery of standardized analytical quality control tests conforming to Iranian Food and Drug Administration (IFDA) requirements.
- Viability: ≥80% viable autologous lymphocytes
- Sterility: 14-day USP sterility, rapid endotoxin, mycoplasma-negative
- Identity: CAR transduction efficiency quantified by flow cytometry
CLINICAL SUPPORT
Scientific resources & clinical practice tools
Access standardized referral documentation, toxicity management protocols, and peer-to-peer scientific discussion resources designed for hospital hematology teams:
Physician Referral Dossier (PDF)
Standard Inclusion Checklist
Comprehensive checklist covering mandatory pathology reports, CD19 immunohistochemistry, baseline organ thresholds, and leukapheresis requisition documentation.
Adverse Event Management
CRS & ICANS Protocols
Clinical staging algorithms and intervention guidelines for monitoring cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS), including tocilizumab dosing.
Peer-to-Peer Scientific Exchange
Tumor Board Consultation
Direct virtual or in-person consultation between your hospital tumor board and CARA Yakhteh’s chief medical officers regarding challenging refractory cases or bridging regimens.